Generics Determining Whether to Submit an ANDA or a 505(b)(2) Application  Final 5/9/2019 Clinical Pharmacology; Over the Counter Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-The -Counter Monograph: Study Elements and Considerations   Final 5/9/2019 Pharmacology/Toxicology Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations     Final 5/9/2019 Clinical/Medical Clinical Lactation Studies: Considerations for Study Design     Draft 5/8/2019 Clinical/Medical Postapproval Pregnancy Safety Studies Guidance for Industry     Draft 5/8/2019 Clinical/Medical Submitting Documents Utilizing Real-World Data and Real-World Evidence to FDA for Drugs and Biologics     Draft 5/8/2019 Procedural Attention Deficit Hyperactivity Disorder: Developing Stimulant Drugs for Treatment     Draft 5/3/2019 Biostatistics Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics with Continuous Outcomes    Draft 4/24/2019 Procedural Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles Final 4/24/2019 Pharmaceutical Quality/CMC Bispecific Antibody Development Programs Draft 4/18/2019 Drug Safety REMS: FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary Final 4/4/2019 Labeling Pediatric Information Incorporated Into Human Prescription Drug and Biological Products Labeling Good Review Practice Final 3/27/2019 Rare Diseases Rare Diseases: Natural History Studies for Drug Development Draft 3/25/2019 Clinical / Medical Pediatric HIV Infection: Drug Development for Treatment Final 3/19/2019 Clinical / Antimicrobial Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis Final 3/19/2019 Procedural A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Draft 3/14/2019 Clinical / Medical Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products Final 3/15/2019 Pharmacology / Toxicology Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals Guidance for Industry Final 3/15/2019 Clinical / Medical Cancer Clinical Trial Eligibility Criteria: Brain Metastases Draft 3/13/2019 Clinical / Medical Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients Draft 3/13/2019 Clinical / Medical Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections Draft 3/13/2019 Clinical / Medical Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials Final 3/13/2019 Clinical / Medical Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies Draft 3/13/2019 Labeling Nonproprietary Naming of Biological Products: Update Guidance for Industry Draft 3/8/2019 Compounding Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act  Final 3/4/2019 Pharmaceutical Quality / CMC Pharmaceutical Quality/Manufacturing Standards (CGPM) Quality Considerations for Continuous Manufacturing Draft 2/27/2019 Clinical Pharmacology Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations Draft 2/26/2019 Clinical Pharmacology Bioavailability Studies Submitted in NDAs or INDs – General Considerations Draft 2/26/2019 Clinical / Medical Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products Draft 2/22/2019 Generics Competitive Generic Therapies Draft 2/19/2019 Procedural CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality Draft 2/14/2019 Clinical / Medical Opioid Use Disorder: Developing Depot Buprenorphine Products for Treatment Final 2/7/2019 Product-Specific Guidances for Generic Drug Development Product-Specific Guidances for Generic Drug Development   09/13/2018 Combination Products Principles of Premarket Pathways for Combination Products: Draft Guidance for Industry and FDA Staff Draft 2/6/2019 Clinical / Medical Eosinophilic Esophagitis: Developing Drugs for Treatment Guidance for Industry Draft Guidance 02/06/19 Clinical / Antimicrobial Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices: Guidance for Industry and Food and Drug Administration Staff Final 2/1/2019 Rare Diseases Rare Diseases: Common Issues in Drug Development Guidance for Industry Draft Guidance (Revised) 2/1/19 Procedural Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format Guidance for Industry (PDF – 87KB) Draft Guidance 01/31/19 Procedural Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products (PDF – 164KB) Final Guidance 01/29/19 Electronic Submissions Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (PDF – 121KB) Final Guidance 01/29/19 Procedural REMS Assessment: Planning and Reporting.   (PDF – 667KB) Draft Guidance 01/24/19 Procedural Survey Methodologies to Assess REMS Goals That Relate to Knowledge Guidance for Industry.  (PDF – 501KB) Draft Guidance 01/24/19 Pharmaceutical Quality/CMC Immunogenicity Testing of Therapeutic Protein Products —Developing and Validating Assays for Anti-Drug Antibody Detection Guidance for Industry (PDF – 372KB) Final Guidance 01/23/19 International Council for Harmonisation – Safety S11 Nonclinical Safety Testing in Support of Developing of Pediatric Medicines (PDF – 1.4MB) Draft Guidance 01/22/19 Generics ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs Guidance for Industry (PDF – 135KB) Draft Guidance 1/16/2019 Procedural Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data (PDF – 138KB) Draft Guidance 12/20/2018 Pharmaceutical Quality/Manufacturing Standards (CGMP) Data Integrity and Compliance With Current Good Manufacturing Practice Guidance for Industry (PDF – 127KB) Final Guidance 12/12/2018 Drug Development Tools Biomarker Qualification: Evidentiary Framework Draft Guidance 12/11/2018 Procedural The “Deemed to be a License” Provision of the BPCI Act: Questions and Answers (PDF – 427KB) Draft Guidance 12/11/2018 Procedural Interpretation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009 (PDF – 410KB) Final Guidance 12/11/2018 Biosimilars New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2) (PDF – 679KB) Draft Guidance 12/11/2018 Compounding/Pharmaceutical Quality/Manufacturing Standards (CGMP) Current Good Manufacturing Practice — Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act (PDF – 476KB) Draft Guidance 12/10/2018 International Council for Harmonisation – Safety S11 Nonclinical Safety Testing in Support of Developing of Pediatric Medicines (PDF – 1.4MB) Draft Guidance 01/22/19 Labeling Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway (PDF – 85KB) Final Guidance 01/22/19 Advertising Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs (PDF – 303KB) Draft Guidance, Revision II 08/05/15 Advertising Direct-to-Consumer Television Advertisements — FDAAA DTC Television Ad Pre-Dissemination Review Program (PDF – 314KB) Draft Guidance 03/12/12 Advertising Consumer-Directed Broadcast Advertisements (PDF – 36KB) Final Guidance 08/01/99 Advertising Consumer-Directed Broadcast Advertisements Questions and Answers (PDF – 83KB) Final Guidance 08/01/99 Advertising Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics (PDF – 118KB) Draft Guidance 01/13/14 Advertising Industry-Supported Scientific and Educational Activites (PDF – 428KB) Final Guidance 12/03/97 Advertising Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices (PDF – 136KB) Draft Guidance 06/17/14 Advertising Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (PDF – 176KB) Draft Guidance 06/17/14 Advertising Presenting Risk Information in Prescription Drug and Medical Device Promotion (PDF – 933KB) Draft Guidance 05/27/09 Advertising Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling-Final (PDF – 115KB) Final Guidance 12/11/17 Advertising Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements  (PDF – 161KB) Draft Guidance 10/16/18 Clinical / Antimicrobial; Animal Rule Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax Guidance for Industr (PDF – 116KB) Final Guidance 05/23/18 Animal Rule Product Development Under the Animal Rule (PDF – 574KB) Final Guidance 10/27/15 Biopharmaceutics Bioanalytical Method Validation Guidance for Industry (PDF – 386KB) Final Guidance 05/21/18 Biopharmaceutics Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action (PDF – 727KB) Draft Guidance 04/03/03 Biopharmaceutics Statistical Information from the June 1999 Draft Guidance and Statistical Information for In Vitro Bioequivalence Data Posted on August 18, 1999 (PDF – 191KB) Draft Guidance 04/11/03 Biopharmaceutics Topical Dermatologic Corticosteroids: in Vivo Bioequivalence (PDF – 2.6MB) Final Guidance 06/02/95 Biopharmaceutics Dissolution Testing of Immediate Release Solid Oral Dosage Forms (PDF – 130KB) Final Guidance 08/01/97 Biopharmaceutics Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations (PDF – 170KB) Final Guidance 09/01/97 Biopharmaceutics Food-Effect Bioavailability and Fed Bioequivalence Studies (PDF – 217KB) Final Guidance 12/01/02 Biopharmaceutics Metaproterenol Sulfate and Albuterol Metered Dose Inhalers In Vitro (PDF – 744KB) Final Guidance 06/27/89 Biopharmaceutics Statistical Approaches to Establishing Bioequivalence (PDF – 130KB) Final Guidance 02/01/01 Biopharmaceutics Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System. Guidance for Industry (PDF – 161KB) Final Guidance 12/22/17 Biopharmaceutics Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (PDF – 128KB) Draft Guidance 12/04/13 Biopharmaceutics Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations (PDF – 805KB) Draft Guidance 03/17/14 Biopharmaceuticals Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances Guidance for Industry (PDF – 103KB) Final Guidance 08/08/18 Biosimilars Scientific Considerations in Demonstrating Biosimilarity to a Reference Product (PDF – 169KB) Final Guidance 04/28/15 Biosimilars Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product (PDF – 144KB) Final Guidance 04/28/15 Biosimilars Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product (PDF – 150KB) Final Guidance 12/28/16 Biosimilars Questions and Answers on Biosimilar Development and the BPCI Act (PDF – 343KB) Final Guidance 12/11/2018 Biosimilars Considerations in Demonstrating Interchangeability With a Reference Product Guidance for Industry (PDF – 229KB) Draft Guidance 01/17/17 Biosimilars; Procedural Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products Guidance for Industry (PDF – 184KB) Draft Guidance 06/04/18 Clinical/Medical; Biostatistics Multiple Endpoints in Clinical Trials Guidance for Industry (PDF – 687KB)   Draft Guidance  01/12/17 Clinical / Antimicrobial Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment (PDF – 267KB) Final Guidance 10/16/13 Clinical / Antimicrobial Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval (PDF – 83KB) Final Guidance 11/26/10 Clinical / Antimicrobial Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases (PDF – 149KB) Final Guidance 08/01/17 Clinical / Antimicrobial Antiviral Product Development–Conducting and Submitting Virology Studies to the Agency (PDF – 100KB) Final Guidance 06/02/06 Clinical / Antimicrobial Antiviral Product Development–Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting HIV Resistance Data (PDF – 117KB) Final Guidance This final guidance is updated by the draft guidance posted 2/27/14. 06/02/06 Clinical / Antimicrobial Antiviral Product Development–Conducting and Submitting Virology Studies to the Agency : Guidance for Submitting Influenza Resistance Data (PDF – 108KB) Final Guidance 06/02/06 Clinical / Antimicrobial Antiviral Product Development–Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting HBV Resistance Data (PDF – 85KB) Final Guidance 06/02/06 Clinical / Antimicrobial Antiviral Product Development–Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting HCV Resistance Data (PDF – 128KB) Final Guidance 06/02/06 Clinical / Antimicrobial Antiviral Product Development — Conducting and Submitting Virology Studies to the Agency Guidance for Submitting HCV Resistance Data -Attachment to Guidance (PDF – 391KB) Draft Guidance 02/22/13 Clinical / Antimicrobial Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment (PDF – 609KB) Final guidance 11/02/15 Clinical / Antimicrobial Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment Guidance for Industry (PDF – 258KB) Final Guidance 11/06/17 Clinical / Antimicrobial Clinical Development and Labeling of Anti- Infective Drug Products (PDF – 5.1MB) Final Guidance 02/12/01 Clinical / Antimicrobial Clinical Evaluation of Anti-Infective Drugs (Systemic) (PDF – 1.1MB) Final Guidance 09/01/77 Clinical / Antimicrobial Community-Acquired Pneumonia — Developing Antimicrobial Drugs for Treatment (PDF – 492KB) Draft Guidance 01/09/14 Clinical / Antimicrobial Complicated Urinary Tract Infections: Developing Drugs for Treatment (PDF – 381KB) Final Guidance 06/01/18 Clinical / Antimicrobial Helicobacter pylori-Associated Duodenal Ulcer Disease in Adults: Developing Drugs for Treatment (PDF – 148KB) Draft Guidance 10/05/09 Clinical / Antimicrobial Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment (PDF – 377KB) Draft Guidance 05/06/14 Clinical / Antimicrobial Influenza: Developing Drugs for Treatment and/or Prophylaxis (PDF – 417KB) Final Guidance 04/12/11 Clinical / Antimicrobial Microbiological Data for Systemic Antibacterial Drug Products — Development, Analysis, and Presentation (PDF – 162KB) Final Guidance 02/07/18 Clinical / Antimicrobial Neglected Tropical Diseases of the Developing World: Developing Drugs for Treatment or Prevention (PDF – 364KB) Final Guidance 07/03/14 Clinical / Antimicrobial Role of HIV Drug Resistance Testing in Antiretroviral Drug Development (PDF – 238KB) Final Guidance 10/30/07 Clinical / Antimicrobial Smallpox (Variola) Infection: Developing Drugs for Treatment or Prevention (PDF – 120KB) Draft Guidance 07/10/18 Clinical / Antimicrobial Guidance for Industry Acute Bacterial Sinusitis: Developing Drugs for Treatment Final Guidance 10/05/12 Clinical Antimicrobial Acute Bacterial Exacerbations of Chronic Bronchitis in Patients With Chronic Obstructive Pulmonary Disease: Developing Antimicrobial Drugs for Treatment Final Guidance 09/28/12 Clinical / Antimicrobial Guidance for Industry: Acute Bacterial Otitis Media: Developing Drugs for Treatment Final Guidance 10/01/12 Clinical / Antimicrobial Pulmonary Tuberculosis: Developing Drugs for Treatment (PDF – 527KB) Draft Guidance 11/05/13 Clinical / Antimicrobial Complicated Intra-Abdominal Infections: Developing Drugs for Treatment (PDF – 130KB) Final Guidance 05/29/18 Clinical / Antimicrobial Antiviral Product Development — Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting HIV-1 Resistance Data: Attachment to the Guidance (PDF – 167KB) Draft Guidance This draft guidance updates the final guidance posted 6/2/06. 02/27/14 Clinical / Antimicrobial Uncomplicated Gonorrhea: Developing Drugs for Treatment (PDF – 222KB) Final Guidance 08/17/15 Clinical / Antimicrobial Vaginal Microbicides:Development for the Prevention of HIV Infection PDF (PDF – 352KB) Final Guidance 11/18/14 Clinical / Antimicrobial Vulvovaginal Candidiasis: Developing Drugs for Treatment (PDF – 163KB) Draft Guidance 06/30/16 Clinical / Antimicrobial Bacterial Vaginosis: Developing Drugs for Treatment Guidance for Industry (PDF – 290KB) Draft Guidance 07/13/16 Clinical / Antimicrobial Respiratory Syncytial Virus Infection: Developing Antiviral Drugs for Prophylaxis and Treatment Guidance for Industry (PDF – 179KB) Draft Guidance 10/11/17 Clinical / Antimicrobial Uncomplicated Urinary Tract Infections: Developing Drugs for Treatment Guidance for Industry (PDF – 124KB) Draft Guidance 05/09/18 Clinical / Antimicrobial Cytomegalovirus in Transplantation: Developing Drugs to Treat or Prevent Disease (PDF – 457KB) Draft Guidance 05/18/18 Clinical / Antimicrobial Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment Draft Guidance 11/01/18 Clinical / Medical Abuse-Deterrent Opioids-Evaluation and Labeling (PDF – 226KB) Final Guidance 4/1/2015 Clinical / Medical FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND: Frequently Asked Questions (PDF – 108KB)   3/1/2012 Clinical / Medical Acne Vulgaris: Establishing Effectiveness of Drugs Intended for Treatment (PDF – 85KB) Final Guidance 5/21/2018 Clinical / Medical; Biostatistics Adaptive Design Clinical Trials for Drugs and Biologics (PDF – 623KB) Draft Guidance 9/28/2018 Clinical / Medical Allergic Rhinitis: Developing Drug Products for Treatment Guidance for Industry (PDF – 120KB) Final Guidance 9/5/2018 Clinical / Medical Analgesic Indications: Developing Drug and Biological Products (PDF – 818KB) Draft Guidance 2/5/2014 Clinical / Medical Antianxiety Drugs–Clinical Evaluation (PDF – 2MB) Final Guidance 9/1/1977 Clinical / Medical Antidepressant Drugs–Clinical Evaluation (PDF – 2MB) Final Guidance 9/1/1977 Clinical / Medical Assessment of Abuse Potential of Drugs Final Guidance 1/17/2017 Clinical / Medical Calcium DTPA and Zinc DTPA Drug Products- Submitting a New Drug Application (PDF – 168KB) Final Guidance 8/13/2004 Clinical / Medical Cancer Drug and Biological Products – Clinical Data in Marketing Applications (PDF – 119KB) Final Guidance 10/11/2001 Clinical / Medical Chronic Cutaneous Ulcer and Burn Wounds — Developing Products for Treatment (PDF – 106KB) Final Guidance 6/1/2006 Clinical / Medical Chronic Obstructive Pulmonary Disease: Use of the St. George’s Respiratory Questionnaire as a PRO Assessment Tool Guidance for Industry (PDF – 69KB) Final Guidance 3/26/2018 Clinical / Medical Osteoarthritis: Structural Endpoints for the Development of Drugs (PDF – 60KB) Draft Guidance 8/22/2018 Clinical / Medical Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA) (PDF – 369KB) Final Guidance 1/1/1999 Clinical / Medical Rheumatoid Arthritis: Developing Drug Products for Treatment (PDF – 176KB) Draft Guidance 5/30/2013 Clinical / Medical Clinical Evaluation of General Anesthetics (PDF – 890KB) Final Guidance 5/1/1982 Clinical / Medical Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics Final Guidance 12/19/2018 Clinical / Medical Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics Final Guidance 4/21/2015 Clinical / Medical Codevelopment of Two or More New Investigational Drugs for Use in Combination (PDF – 91KB) Final Guidance 6/14/2013 Clinical / Medical; Investigational New Drug Applications; Pharmacology/Toxicology Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products. Questions and Answers (PDF – 14KB) Final Guidance 10/1/2000 Clinical / Medical Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations (PDF – 140KB) Final Guidance 2/18/2016 Clinical / Medical Developing Medical Imaging Drug and Biological Products Part 1: Conducting Safety Assessments (PDF – 271KB) Final Guidance 6/17/2004 Clinical / Medical Developing Medical Imaging Drug and Biological Products Part 2: Clinical Indications (PDF – 231KB) Final Guidance 6/17/2004 Clinical / Medical Developing Medical Imaging Drug and Biological Products Part 3: Design, Analysis, and Interpretation of Clinical Studies (PDF – 307KB) Final Guidance 6/17/2004 Clinical / Medical Developing Products for Weight Management Revision 1 (PDF – 91KB) Draft Guidance 2/15/2007 Clinical / Medical Development and Use of Risk Minimization Action Plans March 2005 (PDF – 128KB) Final Guidance 3/24/2005 Clinical / Medical Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention (PDF – 265KB) Draft Guidance 3/3/2008 Clinical / Medical Diabetes Mellitus — Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes (PDF – 47KB) Final Guidance 12/17/2008 Clinical / Medical Guidance for Clinical Trial Sponsors – Establishment and Operation of Clinical Trial Data Monitoring Committees file updated with new OMB expiration date 2-4-13 3/1/2006 Clinical / Medical Estrogen and Estrogen/Progestin Drug Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms — Recommendations for Clinical Evaluation (PDF – 166KB) Draft Guidance 1/31/2003 Clinical / Medical Evaluating the Risks of Drug Exposure in Human Pregnancies  (PDF – 3.1MB) Final Guidance 4/27/2005 Clinical / Medical Exocrine Pancreatic Insufficiency Drug Products–Submitting New Drug Applications (PDF – 70KB) Final Guidance 4/13/2006 Clinical / Medical FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products (PDF – 58KB) Final Guidance 12/1/1998 Clinical / Medical FDA Requirements for Approval of Drugs to Treat Non-Small Cell Lung Cancer (PDF – 1.6MB) Final Guidance 3/2/1998 Clinical / Medical Format and Content of the Clinical and Statistical Sections of an Application: section II.G., Integrated Summary of Effectiveness Data, of this guidance is superseded by the guidance for industry Integrated Summary of Effectiveness  (PDF – 1.1MB) Final Guidance 7/1/1988 Clinical / Medical Formatting, Assembling and Submitting New Drug and Antibiotic Applications* (PDF – 1.7MB) Final Guidance 2/1/1987 Clinical / Medical General Considerations for the Clinical Evaluation of Drugs (PDF – 1.4MB) Final Guidance 1/1/1997 Clinical / Medical General Considerations for the Clinical Evaluation of Drugs in Infants and Children (PDF – 2.2MB) Final Guidance 9/1/1977 Clinical / Medical Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention (PDF – 113KB) Draft Guidance 1/28/2005 Clinical / Medical Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment March 2005 (PDF – 226KB) Final Guidance 3/24/2005 Clinical/ Medical Guideline for Postmarketing Reporting of Adverse Drug Experiences (PDF – 3.6MB) Final Guidance 3/1/1992 Clinical / Medical Exception from Informed Consent Requirements for Emergency Research (PDF – 341KB) Final Guidance 4/1/2013 Clinical / Medical Guidance for the Development of Vaginal Contraceptive Drugs (NDA)[ (PDF – 465KB) Final Guidance 3/2/1998 Clinical / Medical Hypnotic Drugs–Clinical Evaluation (PDF – 1.7MB) Final Guidance 9/1/1977 Clinical / Medical; Pharmaceutical Quality/CMC Immunogenicity Assessment for Therapeutic Protein Products  (PDF – 242KB) Final Guidance 8/13/2014 Clinical / Medical Integration of Dose-Counting Mechanisms into MDI Drug Products (PDF – 125KB) Final Guidance 3/1/2003 Clinical / Medical Internal Radioactive Contamination —Development of Decorporation Agents (PDF – 177KB) Final Guidance 3/1/2006 Clinical / Medical Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs (PDF – 369KB) Final Guidance 12/3/2012 Clinical / Medical Investigational New Drug Applications (INDs)-Determining Whether Human Research Studies Can Be Conducted Without an IND (PDF – 305KB) Final Guidance 9/10/2013 Clinical / Medical Irritable Bowel Syndrome — Clinical Evaluation of Products for Treatment (PDF – 317KB) Final Guidance 5/30/2012 Clinical / Medical Levothyroxine Sodium Tablets – In Vivo Pharmacokinetic and Bioavailability Studies and In Vitro Dissolution Testing (PDF – 27KB) Final Guidance 2/1/2001 Clinical / Medical Local Anesthetics–Clinical Evaluation (PDF – 1MB) Final Guidance 3/2/1998 Clinical / Medical ; Biostatistics Non-Inferiority Clinical Trials (PDF – 474KB) Final Guidance 11/7/2016 Clinical / Medical Pediatric Use Supplements–Content and Format (PDF – 24KB) Final Guidance 5/1/1996 Clinical / Medical Oncologic Drugs Advisory Committee Discussion on FDA Requirements or Approval of New Drugs for Treatment of Colon and Rectal Cancer (PDF – 1.5MB) Final Guidance 3/2/1998 Clinical / Medical Orally Inhaled and Intranasal Corticosteroids: Evaluation of the Effects on Growth in Children (PDF – 82KB) Final Guidance 3/5/2007 Clinical / Medical Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval (PDF – 287KB) Final Guidance 10/6/2014 Clinical / Medical Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (final) (PDF – 295KB) Final Guidance 12/8/2009 Clinical / Medical Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report (PDF – 95KB) Final Guidance 8/1/1997 Clinical / Medical Premarketing Risk Assessment (PDF – 130KB) Final Guidance 3/24/2005 Clinical / Medical Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products. (PDF – 129KB) Final Guidance 5/14/1998 Clinical / Medical Prussian Blue Drug Products — Submitting a New Drug Application (PDF – 159KB) Final Guidance 1/1/2003 Clinical / Medical Psychoactive Drugs in Infants and Children–Clinical Evaluation (PDF – 17.9MB) Final Guidance 3/2/1998 Clinical / Medical Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application (PDF – 6.8MB) Final Guidance 6/3/2009 Clinical / Medical Clinical Trial Imaging Endpoint Process Standards Guidance for Industry (PDF – 186KB) Final Guidance 4/26/2018 Clinical / Medical Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs (PDF – 1.8MB) Final Guidance 7/22/1993 Clinical / Medical Study of Drugs Likely to be used in the Elderly (PDF – 1.2MB) Final Guidance 11/1/1989 Clinical / Medical Summary for New Drug and Antibiotic Applications–Format and Content of the Summary for New Drug and Antibiotic Applications (PDF – 1.3MB) Final Guidance 2/1/1987 Clinical / Medical Systemic Lupus Erythematosus –Developing Drugs for Treatment (PDF – 168KB) Final Guidance 6/21/2010 Clinical / Medical; Procedural The Use of Clinical Holds Following Clinical Investigator Misconduct (PDF – 37KB)   9/1/2004 Clinical / Medical Waiver of IRB Requirements for Drug and Biological Product Studies (PDF – 30KB) Final Guidance 1/1/2006 Clinical / Medical Suicidal Ideation and Behavior: Prospective Assessment of Occurrance in Clinical Trials Revised Draft Guidance 8/14/2012 Clinical / Medical; Procedural Qualification Process for Drug Development Tools: (Attachment) Qualification of Exacerbations of Chronic Pulmonary Disease Tool for Measurement of Symptoms of Acute Bacterial Exacerbation of Chronic Bronchitis in Patients With Chronic Obstructive Pulmonary Disease (PDF – 80KB) Draft Guidance 1/9/2014 Clinical / Medical Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products for Treatment (PDF – 337KB) Draft Guidance 3/10/2014 Clinical / Medical Upper Facial Lines: Developing Botulinum Toxin Drug Products (PDF – 240KB) Draft Guidance 8/5/2014 Clinical / Medical Migraine: Developing Drugs for Acute Treatment (PDF – 115KB) Final Guidance 2/15/2018 Clinical / Medical Evaluating Drug Effects on the Ability to Operate a Motor Vehicle (PDF – 104KB) Final Guidance 11/8/2017 Clinical / Medical Alcoholism: Developing Drugs for Treatment (PDF – 350KB) Draft Guidance 2/11/2015 Clinical / Medical Duchenne Muscular Dystrophy and Related Dystrophinopathies: Developing Drugs for Treatment Guidance for Industry (PDF – 119KB) Final Guidance 2/15/2018 Clinical / Medical; Pharmacology / Toxicology Testicular Toxicity: Evaluation During Drug Development Guidance for Industry (PDF – 180KB) Final Guidance 10/24/2018 Clinical / Medical Gastroparesis: Clinical Evaluation of Drugs for Treatment  (PDF – 197KB) Draft Guidance 7/22/2015 Clinical / Medical Head Lice Infestation: Developing Drugs for Topical Treatment Guidance for Industry (PDF – 233KB) Final Guidance 10/5/2016 Clinical / Medical Nonallergic Rhinitis: Developing Drug Products for Treatment (PDF – 75KB) Final Guidance 9/5/2018 Clinical / Medical Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease, a Patient-Reported Outcome Instrument for the Measurement of Severity of Respiratory Symptoms in Stable Chronic Obstructive Pulmonary Disease: Qualification for Exploratory Use Guidance for Industry (PDF – 50KB) Draft Guidance 3/8/2016 Clinical / Medical Recurrent Herpes Labialis: Developing Drugs for Treatment and Prevention (PDF – 153KB) Final Guidance 11/6/2017 Clinical / Medical Ulcerative Colitis: Clinical Trial Endpoints Guidance for Industry (PDF – 565KB) Draft 8/5/2016 Clinical / Medical Low Sexual Interest, Desire, and/or Arousal in Women: Developing Drugs for Treatment Guidance for Industry (PDF – 298KB) Draft Guidance 10/25/2016 Clinical / Medical Collection of Race and Ethnicity Data in Clinical Trials – Guidance for Industry and FDA Staff (PDF – 896KB) Final Guidance 10/26/2016 Clinical / Medical Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment Guidance for Industry (PDF – 96KB) Final Guidance 2/12/2018 Clinical / Medical Delayed Graft Function in Kidney Transplant: Developing Drugs for Prevention: Guidance for Industry (PDF – 267KB) Draft Guidance 3/22/2017 Clinical / Medical Pediatric Gastroesophageal Reflux Disease: Developing Drugs for Treatment Guidance for Industry (PDF – 311KB) Draft Guidance 10/26/2017 Clinical / Medical Establishing Effectiveness for Drugs Intended to Treat Male Hypogonadotropic Hypogonadism Attributed to Nonstructural Disorders Guidance for Industry (PDF – 66KB) Final Guidance 5/18/2018 Clinical / Medical Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment (PDF – 132KB) Draft Guidance 2/15/2018 Clinical / Medical Alzheimer’s Disease: Developing Drugs for Treatment Guidance for Industy (PDF – 61KB) Draft Guidance 2/15/2018 Clinical / Medical Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients 4 Years of Age and Older (PDF – 51KB) Draft Guidance 2/15/2018 Clinical / Medical Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs (PDF – 71KB) Final Guidance 10/2/2018 Clinical / Medical Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials (PDF – 117KB) Draft Guidance 4/6/2018 Clinical / Medical Assessment of Pressor Effects of Drugs Guidance for Industry (PDF – 106KB) Draft Guidance 5/30/2018 Clinical / Medical Epidermolysis Bullosa: Developing Drugs for Treatment of Cutaneous Manifestations; Draft Guidance for Industry (PDF – 132KB) Draft Guidance 6/15/2018 Clinical / Medical Major Depressive Disorder: Developing Drugs for Treatment  (PDF – 291KB) Draft Guidance 6/20/2018 Clinical / Medical Hypertension: Conducting Studies of Drugs to Treat Patients on a Background of Multiple Antihypertensive Drugs Guidance for Industry (PDF – 57KB) Draft Guidance 7/13/2018 Clinical / Medical Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development: Guidance for Industry (PDF – 84KB) Draft Guidance 7/23/2018 Clinical / Medical Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment Guidance for Industry (PDF – 67KB) Draft Guidance 8/6/2018 Clinical / Medical Hematologic Malignancy and Oncologic Disease: Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development Guidance for Industry (PDF – 61KB) Draft guidance 8/23/2018 Clinical / Medical Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment Guidance for Industry (PDF – 174KB) Draft Guidance 10/15/2018 Clinical/Medical Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment (PDF – 98KB) Draft Guidance 12/3/2018 Clinical / Medical Nonmetastatic, Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials (PDF – 72KB) Draft Guidance 11/13/2018 Clinical / Medical Hypertension: Developing Fixed-Dose Combination Drugs for Treatment Guidance for Industry Final Guidance 11/6/2018 Clinical Pharmacology Clinical Lactation Studies–Study Design, Data Analysis, and Recommendations for Labeling (PDF – 363KB) Draft Guidance 2/8/2005 Clinical Pharmacology Exposure-Response Relationships — Study Design, Data Analysis, and Regulatory Applications (PDF – 221KB) Final Guidance 5/5/2003 Clinical Pharmacology Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application  (PDF – 519KB) Final Guidance 2/1/1987 Clinical Pharmacology Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing and Labeling (PDF – 319KB) Draft Guidance 3/22/2010 Clinical Pharmacology Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling (PDF – 222KB) Final Guidance 5/30/2003 Clinical Pharmacology Pharmacokinetics in Pregnancy — Study Design, Data Analysis, and Impact on Dosing and Labeling (PDF – 324KB) Draft Guidance 11/1/2004 Clinical Pharmacology Population Pharmacokinetics (PDF – 135KB) Final Guidance 2/1/1999 Clinical Pharmacology Clinical Drug Interaction Studies — Study Design, Data Analysis, and Clinical Implications Guidance for Industry (PDF – 224KB) Draft Guidance 10/25/2017 Clinical Pharmacology Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling (PDF – 131KB) Final Guidance 1/29/2013 Clinical Pharmacology General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products (PDF – 375KB) Draft Guidance 12/8/2014 Clinical Pharmacology Physiologically Based Pharmacokinetic Analyses — Format and Content Guidance for Industry (PDF – 87KB) Final Guidance 9/4/2018 Clinical Pharmacology In Vitro Metabolism- and Transporter- Mediated Drug-Drug Interaction Studies Guidance for Industry (PDF – 396KB) Draft Guidance 10/25/2017 Clinical Pharmacology Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease; Guidance for Industry (PDF – 91KB) Final Guidance 10/15/2018 Clinical Pharmacology / Over-the-Counter Maximal Usage Trials for Topical Active Ingredients Being Considered for Inclusion in an Over-The-Counter Monograph: Study Elements and Considerations (PDF – 139KB) Draft Guidance 5/22/2018 Combination Products Coronary Drug-Eluting Stents— Nonclinical and Clinical Studies (PDF – 502KB) Draft 03/26/08 Combination Products Coronary Drug-Eluting Stents— Nonclinical and Clinical Studies Companion Document (PDF – 212KB) Draft Guidance 03/27/08 Combination Products Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4 – Draft Guidance for Industry and FDA Staff   4/1/2013 Compliance Review of FDA’s Implementation of the Drug Export Amendments of 1986 (PDF – 2MB) Final Guidance 11/1/1989 Compliance Good Laboratory Practice Regulations Questions and Answers  (PDF – 2.2MB) Final Guidance 3/2/1998 Compliance Nuclear Pharmacy Guideline Criteria for Determining When to Register as a Drug Establishment (PDF – 3.5MB) Final Guidance 3/2/1998 Compliance Street Drug Alternatives (PDF – 11KB) Final Guidance 3/1/2000 Compliance Prescription Drug Marketing Act — Donation of Prescription Drug Samples to Free Clinics (PDF – 38KB) Final Guidance 3/1/2006 Compliance Prescription Drug Marketing Act (PDMA) Requirements- Questions and Answers (PDF – 112KB) Final Guidance 11/13/2006 Compliance Guidance for Industry: Computerized Systems Used in Clinical Investigations (PDF – 53KB) Final Guidance 5/10/2007 Compliance  Guidance for Industry: Bar Code Label Requirements (PDF – 72KB)   4/2011 Compliance Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products (PDF – 595KB) Final Guidance 5/4/2011 Compliance Marketed Unapproved Drugs — Compliance Policy Guide (PDF – 164KB) Final Guidance 9/19/2011 Compliance; Over-the-Counter Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions (PDF – 89KB) Final Guidance 1/11/2017 Compliance Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular Related Imagery Guidance for Industry (PDF – 193KB) Final Guidance 11/6/2017 Compliance Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry (PDF – 78KB) Draft Guidance 12/18/2017 Compliance Enforcement Policy — OTC Sunscreen Drug Products Marketed Without an Approved Application (PDF – 163KB) Final Guidance 5/22/2018 Compounding / User Fees Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act (PDF – 119KB) Final Guidance 8/3/2015 Compounding / Pharmaceutical Quality/Manufacturing Standards (CGMP) Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities (PDF – 646KB) Final Guidance 1/12/2017 Compounding / Pharmaceutical Quality/Manufacturing Standards (CGMP) Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application (PDF – 556KB) Final Guidance 1/18/2018 Compounding / Drug Safety Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF – 434KB) Final Guidance 9/28/2018 Compounding / Procedural Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” (PDF – 191KB) Final 12/30/2016 Compounding / Pharmaceutical Quality/Manufacturing Standards (CGMP) Current Good Manufacturing Practice — Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act (PDF – 223KB) Draft Guidance 7/1/2014 Compounding / Procedural Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF – 134KB) Revised Final Guidance 1/13/2017 Compounding Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF – 349KB) Final Guidance 12/28/2016 Compounding Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF – 81KB) Draft Guidance 4/15/2016 Compounding Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF – 87KB) Final Guidance 5/10/2018 Compounding Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF – 468KB) Final Guidance 1/18/2018 Compounding Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF – 553KB) Final Guidance 1/18/2018 Procedural / Compounding Insanitary Conditions at Compounding Facilities Guidance for Industry (PDF – 343KB) Draft Guidance 9/25/2018 Compounding Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities Guidance for Industry (PDF – 307KB) Final Guidance 9/25/2018 Compounding Compounding and Repackaging of Radiopharmaceuticals By Outsourcing Facilities Guidance for Industry (PDF – 324KB) Final Guidance 9/25/2018 Concept Papers PDUFA Pilot Project: Proprietary Name Review – Concept Paper (PDF – 186KB) Final Concept Paper 10/07/08 Drug Development Tools Qualification of Biomarker Plasma Fibrinogen in Studies Examining Exacerbations and/or All- Cause Mortality in Patients With Chronic Obstructive Pulmonary Disease Guidance for Industry (PDF – 39KB) Final Guidance 09/14/16 Procedural; Clinical / Medical Qualification Process for Drug Development Tools (PDF – 499KB) Final Guidance 01/06/14 Drug Development Tools Qualification of Biomarker Total Kidney Volume in Studies for Treatment of Autosomal Dominant Polycystic Kidney Disease Draft Guidance for Industry (PDF – 32KB) Final Guidance 09/15/16 Drug Development Tool Guidance on Qualification of Biomarker — Galactomannan in studies of treatments of invasive Aspergillosis (PDF – 141KB) Final Guidance 11/13/15 Drug Development Tools Biomarker Qualification: Evidentiary Framework (PDF – 346KB) Draft Guidance 12/11/2018 Drug Safety Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets (PDF – 501KB) Final Guidance 5/14/2013 Drug Safety Classifying Significant Posmarketing Drug Safety Issues (PDF – 288KB) Draft Guidance 3/8/2012 Drug Safety Drug-Induced Liver Injury: Premarketing Clinical Evaluation  Final Guidance 7/29/2009 Drug Safety Format and Content of a REMS Document Guidance for Industry (PDF – 240KB) Draft Guidance 10/11/2017 Drug Safety Medication Guides — Adding a Toll-Free Number for Reporting Adverse Events (PDF – 67KB) Final Guidance 6/8/2009 Drug Safety Medication Guides — Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS) (PDF – 91KB) Final Guidance 11/17/2011 Drug Safety Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic (PDF – 290KB) Final Guidance 4/11/2018 Drug Safety Postmarketing Studies and Clinical Trials — Implementation of Section 505(O)(3) of the Federal Food, Drug, and Cosmetic Act (PDF – 276KB) Final Guidance 3/31/2011 Drug Safety Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report) (PDF – 116KB) Final Guidance 11/28/2016 Drug Safety Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors (PDF – 608KB) Draft Guidance 4/23/2013 Drug Safety Safety Labeling Changes — Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (PDF – 118KB) Final Guidance 7/30/2013 Drug Safety Safety Reporting Requirements for INDs (Investigational New Drug Applications) and BA/BE (Bioavailability/Bioequivalence) Studies (PDF – 227KB) Final Guidance 12/19/2012 Drug Safety Safety Reporting Requirements for INDs and BA/BE Studies- Small Entity Compliance Guide (PDF – 35KB) Final Guidance 12/19/2012 Drug Safety Best Practices in Developing Proprietary Names for Drugs (PDF – 279KB) Draft Guidance 5/28/2014 Drug Safety Over-the-Counter Pediatric Oral Liquid Drug Products Containing Acetaminophen (PDF – 82KB) Final Guidance 8/4/2015 Drug Safety Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry (PDF – 196KB) Draft Guidance 4/6/2015 Drug Safety Safety Assessment for IND Safety Reporting Guidance for Industry (PDF – 411KB) Draft Guidance 12/16/2015 Drug Safety Safety Considerations for Product Design to Minimize Medication Errors Guidance for Industry (PDF – 212KB) Final Guidance 4/11/2016 Drug Safety FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary Guidance for Industry (PDF – 129KB) Draft Guidance 9/20/2016 Drug Safety Development of a Shared System REMS Guidance for Industry  (PDF – 99KB) Draft Guidance 5/31/2018 Drug Safety Waivers of the Single, Shared System REMS Requirement; Draft Guidance for Industry (PDF – 91KB) Draft Guidance 5/31/2018 Drug Safety; Biostatistics Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products Guidance for Industry (PDF – 227KB) Draft Guidance 11/6/2018 Electronic Submissions Providing Regulatory Submissions in Electronic Format –Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling (PDF – 76KB) Draft Guidance 9/1/2017 Electronic Submissions Indexing Structured Product Labeling (PDF – 51KB) Final Guidance 6/2/2008 Electronic Submissions Providing Regulatory Submissions in Electronic Format — Content of Labeling (PDF – 43KB) Final Guidance 4/20/2005 Electronic Submissions Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing (PDF – 103KB) Final Guidance 5/28/2009 Electronic Submissions Providing Regulatory Submissions in Electronic Format; General Considerations (PDF – 54KB) Final Guidance 1/1/1999 Electronic Submissions Providing Submissions in Electronic Format — Postmarketing Safety Reports (PDF – 124KB) Draft Guidance 6/9/2014 Electronic Submissions Providing Regulatory Submissions in Electronic Format– Receipt Date (PDF – 218KB) Final Guidance 2/10/2014 Electronic Submissions SPL Standard for Content of Labeling Technical Qs & As (PDF – 58KB) Draft Guidance 10/1/2009 Electronic Submissions Providing Regulatory Submissions in Electronic Format — Standardized Study Data (PDF – 132KB) Final Guidance 12/17/2014 Electronic Submissions BIORESEARCH MONITORING TECHNICAL CONFORMANCE GUIDE (PDF – 697KB) Draft Guidance 2/21/2018 Electronic Submissions Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER SubmissionsGuidance for Industry (PDF – 110KB) Draft Guidance 2/21/2018 Electronic Submissions Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications  (PDF – 107KB) Final Guidance 4/24/2018 Electronic Submissions Providing Submissions in Electronic Format – Postmarket Non-Expedited ICSRs Technical Questions and Answers (PDF – 104KB) Final Guidance 7/24/2013 Electronic Submissions Providing Regulatory Submissions in Electronic Format — Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act (PDF – 81KB) Final Guidance 12/17/2014 Electronic Submissions Reporting Drug Sample Information Under Section 6004 of the Affordable Care Act (PDF – 114KB) Draft Guidance 7/10/2014 Electronic Submissions Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs (PDF – 252KB) Draft Guidance 4/21/2015 Electronic Submissions Part 11, Electronic Records; Electronic Signatures — Scope and Application   8/1/2003 Electronic Submissions; FDAAA Providing Regulatory Submissions in Electronic Format–Submission of Manufacturing Establishment Information Guidance for Industry (PDF – 85KB) Draft Guidance 12/28/2016 Electronic Submissions Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions:Compliance with Section 4020) of The Public Health Service Act, Added By Title VIII of The Food and Drug Administration Amendments Act of 2007 (PDF – 314KB) Draft 4/2008 Generics 180-Day Exclusivity When Multiple ANDAs Are Submitted on the Same Day (PDF – 138KB) Final Guidance 7/1/2003 Generics; Procedural Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act. (PDF – 25KB) Final Guidance 3/1/2000 Generics Handling and Retention of Bioavailability BA and Bioequivalence BE Testing Samples (PDF – 190KB) Final Guidance 5/25/2004 Generics Individual Product Bioequivalence Recommendations for Specific Products (PDF – 80KB) Final Guidance 6/10/2010 Generics Letter describing efforts by the CDER and the ORA to clarify the responsibilities of CDER chemistry review scientists and ORA field investigators in the new and abbreviated drug approval process in order to reduce duplication or redundancy in the process (PDF – 274KB) Final Guidance 10/1/1994 Generics Letter on incomplete Abbreviated Applications, Convictions Under GDEA, Multiple Supplements, Annual Reports for Bulk Antibiotics, Batch Size for Transdermal Drugs, Bioequivalence Protocols, Research, Deviations from OGD Policy (PDF – 1.9MB) Final Guidance 9/1/1994 Generics Letter on the Provision of new information pertaining to new bioequivalence guidelines and refuse-to-file letters (PDF – 254KB) Final Guidance 7/1/1992 Generics Letter on the provision of new procedures and policies affecting the generic drug review process (PDF – 608KB) Final Guidance 3/1/1989 Generics Letter on the request for cooperation of regulated industry to improve the efficiency and effectiveness of the generic drug review process, by assuring the completeness and accuracy of required information and data submissions (PDF – 917KB) Final Guidance 11/1/1990 Generics Letter on the response to 12/20/1984 letter from the Pharmaceutical Manufacturers Association about the Drug Price Competition and Patent Term Restoration Act (PDF – 392KB) Final Guidance 3/1/1985 Generics Letter to all ANDA and AADA applicants about the Generic Drug Enforcement Act of 1992 (GDEA), and the Office of Generic Drugs intention to refuse-to-file incomplete submissions as required by the new law (PDF – 233KB) Final Guidance 1/1/1993 Generics Letter to regulated industry notifying interested parties about important detailed information regarding labeling, scale-up, packaging, minor/major amendment criteria and bioequivalence requirements (PDF – 908KB) Final Guidance 8/1/1993 Generics Revising ANDA Labeling Following Revision of the RLD Labeling (PDF – 19KB) Final Guidance 4/26/2000 Generics Submission of Summary Bioequivalence Data for Abbreviated New Drug Applications (PDF – 137KB) Final Guidance 5/5/2011 Generics Variations in Drug Products that May Be Included in a Single ANDA (PDF – 107KB) Final Guidance 12/1/1998 Generics; User Fees ANDA Submissions — Content and Format of Abbreviated New Drug Applications (PDF – 308KB) Final Guidance 9/24/2018 Generics; User Fees ANDA Submissions–Amendments to Abbreviated New Drug Applications Under GDUFA; Guidance for Industry  (PDF – 219KB) Final Guidance 7/3/2018 Generics; User Fees ANDA Submissions – Prior Approval Supplements Under GDUFA  (PDF – 147KB) Final Guidance 10/4/2017 Generics; User Fees ANDA Submissions — Refuse to Receive for Lack of Justification of Impurity Limits (PDF – 326KB) Final Guidance 8/24/2016 Generics; User Fees How to Obtain a Letter from FDA Stating that Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable REMS for RLD (PDF – 72KB) Draft Guidance 12/4/2014 Generics Acceptability of Draft Labeling to Support Abbreviated New Drug Application Approval; Guidance for Industry (PDF – 53KB) Draft Guidance 10/5/2015 Generics; User Fees; Pharmaceutical Quality/CMC Completeness Assessments for Type II API DMFs Under GDUFA Guidance for Industry (PDF – 379KB) Final Guidance 10/4/2017 Generics General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products Guidance for Industry (PDF – 520KB) Final Guidance 11/21/2017 Generics Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs Draft Guidance for Industry (PDF – 187KB) Revised Draft Guidance 10/9/2018 Generics Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn Guidance for Industry (PDF – 94KB) Draft Guidance 7/8/2016 Generics; User Fees Self-Identification of Generic Drug Facilities, Sites, and Organizations; Guidance for Industry (PDF – 268KB) Final Guidance 9/22/2016 User Fees; Generics Generic Drug User Fee Amendments of 2012: Questions and Answers Related to Self- Identification of Facilities, Review of Generic Drug Submissions, and Inspections and Compliance Guidance for Industry (PDF – 131KB) Final Guidance 7/25/2017 Generics Guidance for Industry 180-Day Exclusivity: Questions and Answers (PDF – 240KB) Draft 1/12/2017 Generics Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry (PDF – 200KB) Draft Guidance 1/13/2017 Generics Referencing Approved Drug Products in ANDA Submissions Guidance for Industry (PDF – 155KB) Draft Guidance 1/13/2017 Generics; User Fees ANDA Submissions – Refuse-to- Receive Standards: : Questions and Answers Guidance for Industry (PDF – 153KB) Draft Guidance 10/2/2017 Generics Determining Whether to Submit an ANDA or a 505(b)(2) Application Guidance for Industry Draft Guidance 10/11/2017 Generics; User Fees Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA October 2017 (PDF – 94KB) Draft Guidance 10/13/2017 Generics; User Fees Controlled Correspondence Related to Generic Drug Development Draft Guidance for Industry (PDF – 171KB) Draft Guidance 11/2/2017 Generics; User fees Information Requests and Discipline Review Letters Under the Generic Drug User Fee Amendments; Draft Guidance for Industry (PDF – 81KB) Draft Guidance 12/15/2017 Pharmaceutical Quality/CMC; Generics ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence) Guidance for Industry (PDF – 151KB) Draft Guidance 11/3/2017 Generics Good ANDA Submission Practices Guidance for Industry (PDF – 250KB) Draft Guidance 1/3/2018 Generics Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs Guidance for Industry (PDF – 235KB) Draft Guidance 10/9/2018 User Fees; Generics Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for Industry (PDF – 708KB) Draft Guidance 10/27/2017 Generics; User Fees Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA (PDF – 101KB) Final Guidance 12/3/2018 Good Review Practices Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review (PDF – 1516KB) This guidance has been superseded by Attachment B: Clinical Safety Review of an NDA or BLA of the Good Review Practice: Clinical Review Template (MAPP 6010.3 Rev. 1)that posted Dec 15, 2010 Final 2/2005
Removed 1/26/2011 Good Review Practices Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff : Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance with Section 402(j) of The Public Health Service Act, Added By Title VIII of The Food and Drug Administration Amendments Act of 2007 Final 1/21/2009 Good Review Practices Pharmacology/Toxicology Review Format (PDF – 55KB)   Final 5/2001 Industry Letters Continuation of a series of letters communicating interim and informal generic drug policy and guidance. Availability of Policy and Procedure Guides, and further operational changes to the generic drug review program (PDF – 611KB) Final Guidance 3/2/1998 Industry Letters Fifth of a series of letters providing informal notice about the Act, discussing the statutory mechanism by which ANDA applicants may make modifications in approved drugs where clinical data is required (PDF – 243KB) Final Guidance 3/2/1998 Industry Letters Fourth of a series of letters providing informal notice to all affected parties about policy developments and interpretations regarding the Act. Three year exclusivity provisions of Title I (PDF – 839KB) Final Guidance 3/2/1998 Industry Letters Implementation of the Drug Price Competition and Patent Term Restoration Act. Preliminary Guidance (PDF – 644KB) Final Guidance 3/2/1998 Industry Letters Implementation Plan USP injection nomenclature (PDF – 247KB) Final Guidance 3/2/1998 Industry Letters Seventh of a series of letters about the Act providing guidance on the “130-day exclusivity” provision of section 505(j)(4)(B)(iv) of the FD&C (PDF – 730KB) Final Guidance 3/2/1998 Industry Letters Sixth of a series of informal notice letters about the Act discussing 3-and 5-year exclusivity provisions of sections 505(c)(3)(D) and 505(j)(4)(D) of the FD&C Act (PDF – 538KB) Final Guidance 3/2/1998 Industry Letters Supplement to 10/11/1984 letter about policies, procedures and implementation of the Act (Q&A format) (PDF – 740KB) Final Guidance 3/2/1998 Industry Letters Third of a series of letters regarding the implementation of the Act (PDF – 393KB) Final Guidance 3/2/1998 Industry Letters Year 2000 Letter from Dr. Janet Woodcock Final Guidance 10/19/1998 International Council for Harmonisation – Efficacy E1A The Extent of Population Exposure to Assess Clinical Safety: For Drugs Intended for Long-term Treatment of Non-Life-Threatening Conditions (PDF – 17KB) Final Guidance 3/1/1995 International Council for Harmonisation – Efficacy E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (PDF – 49KB) Final Guidance 3/1/1995 International Council on Harmonisation – Efficacy E2B International Conference on Harmonisation; Guidance on Data Elements for Transmission of Individual Case Safety Reports (PDF – 70KB) Final Guidance 1/15/1998 International Council on Harmonisation – Efficacy E2BM Data Elements for Transmission Of Individual Case Safety Reports (PDF – 162KB) Final Guidance 4/4/2002 International Council on Harmonisation – Efficacy E2B(M) Questions and Answers (PDF – 61KB) Final Guidance 3/9/2005 International Council on Harmonisation – Efficacy E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification; and Appendix to the Implementation Guide — Backwards and Forwards Compatibility Final Guidance 2/21/2014 International Council on Harmonisation- Efficacy E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER) (PDF – 462KB) Final Guidance 7/18/2016 International Council on Harmonisation – Efficacy E2D Postapproval Safety Data Management: Definitions and Standards for Expedited Reporting (PDF – 165KB) Draft Guidance 9/12/2003 International Council on Harmonisation – Efficacy E2E Pharmacovigilance Planning (PDF – 100KB) Final Guidance 3/31/2005 International Council on Harmonisation – Efficacy E2F Development Safety Update Report (PDF – 272KB) Final Guidance 8/22/2011 International Council on Harmonisation – Efficacy E3 Structure and Content of Clinical Study Reports (PDF – 240KB) Final Guidance 7/1/1996 International Council on Harmonisation – Efficacy E3 Structure and Content of Clinical Study Reports – Questions and Answers (R1) (PDF – 141KB) Final Guidance 1/25/2013 International Council on Harmonisation – Efficacy E4 Dose-Response Information to Support Drug Registration (PDF – 49KB) Final Guidance 7/1/1996 International Council on Harmonisation – Efficacy E5 Ethnic Factors in the Acceptability of Foreign Clinical Data (PDF – 79KB) Final Guidance 6/1/2004 International Council on Harmonisation – Efficacy E7 Studies in Support of Special Populations: Geriatrics (PDF – 25KB) Final Guidance 8/1/1994 International Council on Harmonisation – Efficacy E7 Studies in Support of Special Populations; Geriatrics; Questions and Answers (PDF – 85KB) Final Guidance 2/17/2012 International Council on Harmonisation – Efficacy E8 General Considerations for Clinical Trials (PDF – 67KB) Final Guidance 12/1/1997 International Council on Harmonisation – Efficacy ; Biostatistics E9 Statistical Principles for Clinical Trials (PDF – 110KB) Final Guidance 9/1/1998 International Council on Harmonisation – Efficacy ; Biostatistics E10 Choice of Control Group and Related Issues in Clinical Trials (PDF – 93KB) Final Guidance 5/1/2001 International Council on Harmonisation – Efficacy E11 Clinical Investigation of Medicinal Products in the Pediatric Population (PDF – 60KB) Final Guidance 12/1/2000 International Council on Harmonisation – Efficacy E12A Principles for Clinical Evaluation of New Antihypertensive Drugs (PDF – 27KB) Draft Guidance 8/1/2000 International Council on Harmonisation – Efficacy E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs (PDF – 98KB) Final Guidance 10/19/2005 International Council on Harmonisation – Efficacy E15 Pharmacogenomics Definitions and Sample Coding (PDF – 53KB) Final Guidance 4/7/2008 International Council on Harmonisation – Efficacy E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions (PDF – 111KB) Final Guidance 8/10/2011 International Council on Harmonisation – Efficacy E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) (PDF – 484KB) Final Guidance 2/28/2018 International Council on Harmonisation – Efficacy E18 Genomic Sampling and Management of Genomic Data Guidance for Industry (PDF – 98KB) Final Guidance 3/1/2018 International Conference on Harmonization – Efficacy E2C(R2) Periodic Benefit-Risk Evaluation Report – Questions and Answers (PDF – 153KB) Final Guidance 7/18/2016 International Council for Harmonisation – Efficacy E17 General Principles for Planning and Design of Multi-Regional Clinical Trials (PDF – 404KB) Final Guidance 7/18/2018 International Council for Harmonization – Efficacy E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population (PDF – 354KB) Final Guidance 4/10/2018 International Conference on Harmonisation – Efficacy E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs Questions and Answers (R3) Guidance for Industry (PDF – 117KB) Final Guidance 6/13/2017 International Conference on Harmonisation – Efficacy ; Biostatistics E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials (PDF – 222KB) Draft Guidance 10/30/2017 International Council on Harmonisation – Joint Safety/Efficacy (Multidisciplinary) M2 eCTD: Electronic Common Technical Document Specification (PDF – 1020KB) Final Guidance 4/1/2003 International Council on Harmonisation – Joint Safety/Efficacy (Multidisciplinary) M2: eCTD Specification Questions and Answers and Change Requests (PDF – 31KB) Final Guidance 3/14/2005 International Council on Harmonisation – Joint Safety/Efficacy (Multidisciplinary) M2: eCTD Specification Questions & Answers and Change Requests Companion Document Final Guidance 6/3/2013 International Council on Harmonisation – Joint Safety/Efficacy (Multidisciplinary) M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (PDF – 325KB) Final Guidance 1/20/2010 International Council on Harmonisation – Multidisciplinary M3(R2)Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals: Questions and Answers (PDF – 311KB) Final Guidance 2/25/2013 International Council on Harmonisation – Joint Safety/Efficacy (Multidisciplinary) M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use Guidance for Industry (PDF – 269KB) Final Guidance 10/3/2017 International Council on Harmonisation – Joint Safety/Efficacy (Multidisciplinary) M4: The CTD — General Questions and Answers (PDF – 45KB) Final Guidance 12/22/2004 International Council on Harmonisation – Joint Safety/Efficacy (Multidisciplinary) M4: The CTD — Quality (PDF – 131KB) Final Guidance 8/1/2001 International Council on Harmonisation – Joint Safety/Efficacy (Multidisciplinary) M4: The CTD — Quality Questions and Answers /Location Issues (PDF – 86KB) Final Guidance 6/8/2004 International Council on Harmonisation – Joint Safety/Efficacy (Multidisciplinary) M4: The CTD — Efficacy (PDF – 286KB) Final Guidance 8/1/2001 International Council on Harmonisation – Joint Safety/Efficacy (Multidisciplinary) M4: The CTD — Efficacy Questions and Answers (PDF – 165KB) Final Guidance 12/1/2004 International Council on Harmonisation – Joint Safety/Efficacy (Multidisciplinary) M4S: The CTD — Safety (PDF – 116KB) Final Guidance 8/1/2001 International Council on Harmonisation – Joint Safety/Efficacy (Multidisciplinary) M4S: The CTD — Safety Appendices (PDF – 2MB) Final Guidance 8/1/2001 International Council on Harmonisation – Joint Safety/Efficacy (Multidisciplinary) M4: The CTD — Safety Questions and Answers (PDF – 27KB) Final Guidance 2/4/2003 International Council on Harmonisation – Joint Safety/Efficacy (Multidisciplinary) M5International Conference on Harmonisation; Draft Guidance on M5 Data Elements and Standards for Drug Dictionaries (PDF – 406KB) Draft Guidance 9/1/2005 International Council on Harmonisation – Joint Safety/Efficacy (Multidisciplinary) Submitting Marketing Applications According to the ICH/CTD Format: General Considerations (PDF – 175KB) Draft Guidance 9/1/2001 International Council on Harmonisation – Joint Safety/Efficacy (Multidisciplinary) M7(R1) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk (PDF – 1.4MB) Final Guidance 3/13/2018 International Council on Harmonisation – Joint Safety/Efficacy (Multidisciplinary) M8 Electronic Common Technical Document (eCTD) v4.0 DRAFT Implementation Guide v2.0; and eCTD Implementation Package DRAFT Specification for Submission Formats v2.0 Draft Guidance 4/22/2015 International Council on Harmonisation – Joint Safety/Efficacy (Multidisciplinary) M4E(R2): The CTD – Efficacy (PDF – 470KB) Final Guidance Revision 1 7/24/2017 International Council on Harmonisation – Multidisciplinary M9 Biopharmaceutics Classification System-Based Biowaivers (PDF – 460KB) Draft Guidance 10/25/2018 International Council on Harmonisation – Safety The Need for Long-term Rodent Carcinogenicity Studies of Pharmaceuticals (PDF – 100KB) Final Guidance 3/1/1996 International Council on Harmonisation – Safety S1B Testing for Carcinogenicity of Pharmaceuticals (PDF – 145KB) Final Guidance 2/28/1998 International Council on Harmonisation – Safety S1C(R2) Dose Selection for Carcinogenicity Studies of Pharmaceuticals (PDF – 185KB) Final Guidance 9/17/2008 International Council on Harmonisation – Safety S2A Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals (PDF – 123KB) Final Guidance 4/1/1996 International Council on Harmonisation – Safety S2B Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals (PDF – 131KB) Final Guidance 11/21/1997 International Council on Harmonisation – Safety S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use (PDF – 427KB) Final Guidance 6/6/2012 International Council on Harmonisation – Safety S3A Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies (PDF – 46KB) Final Guidance 3/1/1995 International Council on Harmonisation – Safety S3B Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies (PDF – 14KB) Final Guidance 3/1/1995 International Council on Harmonisation – Safety S4A Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing) (PDF – 21KB) Final Guidance 6/25/1999 International Council on Harmonisation – Safety S5A Detection of Toxicity to Reproduction for Medicinal Products S5(R2) Detection of Toxicity to Reproduction for Medicinal Products Toxicity to Male Fertility In November 2005, the ICH incorporated the S5B addendum with S5A and retitled the combined S5 document. The contents of the two guidances were not revised. (PDF – 87KB) Final Guidance 9/1/1994 International Council on Harmonisation – Safety S5B Detection of Toxicity to Reproduction for Medicinal Products: S5(R2) Detection of Toxicity to Reproduction for Medicinal Products Toxicity to Male Fertility In November 2005, the ICH incorporated the S5B addendum with S5A and retitled the combined S5 document. The contents of the two guidances were not revised. (PDF – 98KB) Final Guidance 4/1/1996 International Council on Harmonisation – Safety S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (July 2011) See Attachment Final Guidance 5/17/2012 International Council on Harmonisation – Safety S7A Safety Pharmacology Studies for Human Pharmaceuticals (PDF – 44KB) Final Guidance 7/1/2001 International Council on Harmonisation – Safety S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals (PDF – 52KB) Final Guidance 10/19/2005 International Council on Harmonisation – Safety S8 Immunotoxicity Studies for Human Pharmaceuticals (PDF – 72KB) Final Guidance 4/12/2006 International Council on Harmonisation – Safety S9 Nonclinical Evaluation for Anticancer Pharmaceuticals (PDF – 169KB) Final Guidance 3/5/2010 International Council on Harmonisation – Safety S10 Photosafety Evaluation of Pharmaceuticals (PDF – 256KB) Final Guidance 1/26/2015 International Council for Harmonisation – Safety S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies: Focus on Microsampling (PDF – 149KB) Final Guidance 5/9/2018 International Council for Harmonisation – Safety S9 Nonclinical Evaluation for Anticancer Pharmaceuticals–Questions and Answers (PDF – 536KB) Final Guidance 6/15/2018 International Council for Harmonisation – Safety S5(R3) Detection of Toxicity to Reproduction (PDF – 1.4MB) Draft Guidance 11/9/2017 International Council on Harmonisation – Quality Q1A(R2) Stability Testing of New Drug Substances and Products (PDF – 58KB) Final Guidance 11/1/2003 International Council on Harmonisation – Quality Q1B Photostability Testing of New Drug Substances and Products (PDF – 339KB) Final Guidance 11/1/1996 International Council on Harmonisation – Quality Q1C Stability Testing for New Dosage Forms (PDF – 101KB) Final Guidance 5/9/1997 International Council on Harmonisation – Quality Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products (PDF – 31KB) Final Guidance 1/1/2003 International Council on Harmonisation – Quality Q1E Evaluation of Stability Data (PDF – 221KB) Final Guidance 6/1/2004 International Council on Harmonisation – Quality Q2 (R1)Validation of Analytical Procedures: Text and Methodology [Note: In November 2005, the ICH incorporated Q2B on methodology with the parent guidance Q2A and retitled the combined document Q2(R1). The contents of Q2A and Q2B posted below were not revised.]   11/2005 International Council on Harmonisation – Quality Q2A Text on Validation of Analytical Procedures  (PDF – 25KB) Final Guidance 3/1/1995 International Council on Harmonisation – Quality Q2B Validation of Analytical Procedures: Methodology (PDF – 132KB) Final Guidance 5/19/1997 International Council on Harmonisation – Quality Q3A(R) Impurities in New Drug Substances (PDF – 55KB) Final Guidance 6/6/2008 International Council on Harmonisation – Quality Q3B(R) Impurities in New Drug Products (Revision 2) (PDF – 171KB) Final Guidance 8/4/2006 International Council on Harmonisation – Quality Q3C Impurities: Residual Solvents (PDF – 41KB) Final Guidance 12/24/1997 International Council on Harmonisation – Quality Q3C Tables and List  (PDF – 276KB) Final Guidance 7/24/2017 International Council on Harmonisation – Quality Q3C Impurities: Residual Solvents: Maintenance Procedures for the Guidance for Industry Q3C Procedures/Recommendations 7/24/2017 International Council on Harmonisation – Quality Q3C Appendix 4  (PDF – 120KB) Draft Guidance 3/18/1998 International Council on Harmonisation – Quality Q3C Appendix 5 (PDF – 216KB) Draft Guidance 3/18/1998 International Council on Harmonisation – Quality Q3C Appendix 6 (PDF – 128KB) Draft Guidance 3/18/1998 International Council on Harmonisation – Quality Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions (PDF – 55KB) Final Guidance 2/20/2007 International Council on Harmonisation – Quality Q4B: Annex I: Residue on Ignition/Sulphated Ash General Chapter  (PDF – 58KB) Final Guidance 9/18/2017 International Council on Harmonisation – Quality Q4B: Annex 2: Test for Extractable Volume of Parenteral Preparations General Chapter (PDF – 69KB) Final Guidance 9/18/2017 International Council on Harmonisation – Quality Q4B: Annex 3: Test for Particulate Contamination: Subvisible Particles General Chapter  (PDF – 993KB) Final Guidance 9/18/2017 International Council on Harmonisation – Quality Q4B: Annex 4A: Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter (PDF – 69KB) Final Guidance 9/18/2017 International Council on Harmonisation – Quality Q4B: Annex 4B: Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter (PDF – 69KB) Final Guidance 9/18/2017 International Council on Harmonisation – Quality Q4B: Annex 4C: Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter (PDF – 57KB) Final Guidance 9/18/2017 International Council on Harmonisation – Quality Q4B: Annex 5: Disintegration Test General Chapter (PDF – 69KB) Final Guidance 9/18/2017 International Council on Harmonisation – Quality Q4B: Annex 6: Uniformity of Dosage Units General Chapter (PDF – 53KB) Final Guidance 6/13/2014 International Council on Harmonisation – Quality Q4B: Annex 7(R2): Dissolution Test General Chapter (PDF – 102KB) Final Guidance 6/23/2011 International Council on Harmonisation – Quality Q4B: Annex 8: Sterility Test General Chapter (PDF – 68KB) Final Guidance 9/18/2017 International Council on Harmonisation – Quality Q4B: Annex 9: Tablet Friability General Chapter (PDF – 68KB) Final Guidance 9/18/2017 International Council on Harmonisation – Quality Q4B: Annex 10: Polyacrylamide Gel Electrophoresis General Chapter (PDF – 57KB) Final Guidance 9/18/2017 International Council on Harmonisation – Quality Q4B Annex 11: Capillary Electrophoresis General Chapter (PDF – 93KB) Final Guidance 9/2/2010 International Council on Harmonisation – Quality Q4B Annex 12: Analytical Sieving General Chapter (PDF – 87KB) Final Guidance 9/1/2010 International Council on Harmonisation – Quality Q4B Annex 13: Bulk Density and Tapped Density of Powders General Chapter (PDF – 94KB) Final Guidance 5/24/2013 International Council on Harmonisation; Quality Q4B Annex 14: Bacterial Endotoxins Test General Chapter (PDF – 96KB) Final Guidance 10/15/2013 International Council on Harmonisation – Quality Q5A Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin (PDF – 71KB) Final Guidance 9/1/1998 International Council on Harmonisation – Quality Q5B Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products (PDF – 109KB) Final Guidance 2/1/1996 International Council on Harmonisation – Quality Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products (PDF – 70KB) Final Guidance 7/1/1996 International Council on Harmonisation – Quality Q5D Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products; Availability (PDF – 52KB) Final Guidance 9/21/1998 International Council on Harmonisation – Quality Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process (PDF – 58KB) Final Guidance 6/1/2005 International Council on Harmonisation – Quality Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances Final Guidance 12/29/2000 International Council on Harmonisation – Quality Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products (PDF – 54KB) Final Guidance 8/1/1999 International Council on Harmonisation – Quality Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Guidance for Industry (PDF – 253KB) Final Guidance 9/30/2016 International Council on Harmonisation – Quality Q8(R2) Pharmaceutical Development (PDF – 402KB) Final Guidance 11/20/2009 International Council on Harmonisation – Quality Q9 Quality Risk Management (PDF – 113KB) Final Guidance 6/1/2006 International Council on Harmonisation – Quality Q10 Pharmaceutical Quality System (PDF – 274KB) Final Guidance 4/7/2009 International Council on Harmonisation – Quality Q8, Q9, and Q10 Questions and Answers (PDF – 185KB) Final Guidance 11/1/2011 International Council on Harmonisation – Quality Q8, Q9, & Q10 Questions and Answers — Appendix: Q&As from Training Sessions (Q8, Q9, & Q10 Points to Consider) Final Guidance 7/25/2012 International Council on Harmonisation – Quality Q11 Development and Manufacture of Drug Substances (PDF – 708KB) Final Guidance 11/19/2012 International Council on Harmonisation – Quality Q3D Elemental Impurities (PDF – 685KB) Final Guidance 9/9/2015 International Council on Harmonisation – Quality Q11 Development and Manufacture of Drug Substances–Questions and Answers (Chemical Entities and Biotechnological/Biological Entities) (PDF – 843KB) Final Guidance 2/23/2018 International Council on Harmonisation – Quality Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Questions and Answers Guidance for Industry (PDF – 218KB) Final Guidance 4/19/2018 International Council for Harmonisation-Quality Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Core Guideline Guidance for Industry (PDF – 451KB) Draft Guidance 5/30/2018 International Council for Harmonisation-Quality Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Annex (PDF – 223KB) Draft Guidance 5/30/2018 International Council on Harmonisation – Quality Q3D(R1) ELEMENTAL IMPURITIES (PDF – 177KB) Draft Guidance 7/13/2018 Labeling Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (PDF – 52KB) Final Guidance 1/18/2006 Labeling Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products — Content and Format (PDF – 144KB) Final Guidance 12/2/2016 Labeling Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (PDF – 127KB) Final Guidance 1/18/2006 Labeling Content and Format for Geriatric Labeling (PDF – 38KB) Final Guidance 10/1/2001 Labeling Contents of a Complete Submission for the Evaluation of Proprietary Names (PDF – 146KB) Final Guidance 4/5/2016 Labeling Content and Format of the Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products (PDF – 163KB) Final Guidance 3/22/2010 Labeling Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims (PDF – 144KB) Final Guidance 3/14/2011 Labeling Labeling for Human Prescription Drug and Biological Products — Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information (PDF – 65KB) Final Guidance 10/16/2009 Labeling Labeling for Human Prescription Drug and Biological Products – Implementing the PLR Content and Format Requirements (PDF – 527KB) Final Guidance 2/22/2013 Labeling Public Availability of Labeling Changes in “Changes Being Effected” Supplements (PDF – 26KB) Draft Guidance 9/20/2006 Labeling; Over-the-Counter; Small Entity Compliance Guides Topical Acne Drug Products for Over-the-Counter Human Use–Revision of Labeling and Classification of Benzoyl Peroxide as Safe and Effective (PDF – 123KB) Final Guidance 6/21/2011 Labeling Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products — Content and Format (PDF – 102KB) Final Guidance 10/11/2011 Labeling Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (PDF – 91KB) Final Guidance 12/9/2014 Labeling Naming of Drug Products Containing Salt Drug Substances (PDF – 210KB) Final Guidance 6/16/2015 Labeling Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products-Content and Format (PDF – 208KB) Draft Guidance 12/3/2014 Labeling Nonproprietary Naming of Biological Products Guidance for Industry (PDF – 115KB) Final Guidance 1/12/2017 Labeling Labeling for Biosimilar Products Guidance for Industry (PDF – 285KB) Final Guidance 7/18/2018 Labeling Child-Resistant Packaging Statements in Drug Product Labeling Guidance for Industry (PDF – 96KB) Draft Guidance 8/2/2017 Labeling Gluten in Drug Products and Associated Labeling Recommendations; Draft Guidance for Industry (PDF – 136KB) Draft Guidance 12/12/2017 Labeling Systemic Antibacterial and Antifungal Drugs: Susceptibility Test Interpretive Criteria Labeling for NDAs and ANDAs (PDF – 92KB) Final Guidance 12/13/2017 Labeling Labeling for Combined Hormonal Contraceptives Guidance for Industry (PDF – 437KB) Draft Guidance 12/29/2017 Labeling Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry (PDF – 680KB) Draft Guidance 1/18/2018 Labeling Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry (PDF – 481KB) Draft Guidance 7/6/2018 Labeling Product Identifiers under the Drug Supply Chain Security Act – Questions and Answers (PDF – 363KB) Draft Guidance 9/19/2018 Modernization Act Fast Track Drug Development Programs – Designation, Development, and Application Review: Appendix 2 (PDF – 3.9MB) Final Guidance 12/11/1992 Modernization Act Formal Dispute Resolution: Appeals Above the Division Level (PDF – 30KB) Final Guidance 2/1/2000 Modernization Act; Procedural Implementation of Section 120 of the Food and Drug Administration Modernization Act of 1997-Advisory Committees (PDF – 62KB) Final Guidance 10/1/1998 Modernization Act; Procedural Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997 – Elimination of Certain Labeling Requirements Final Guidance 7/1/1998 Procedural; Modernization Act PET Drug Applications – Content and Format for NDAs and ANDAs: Attachment I: Sample formats for chemistry, manufacturing, and controls (CMC) sections_2011 (PDF – 614KB) Final Guidance 8/31/2011 Procedural; Modernization Act Sample formats for Form FDA 356h_2011 (PDF – 601KB) Draft Guidance 2/2/2011 Modernization Act Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act: Frequently Asked Questions on Pediatric Exclusivity (505A) Final Guidance 5/7/2009 Modernization Act; Procedural Repeal of Section 507 of the Federal Food, Drug and Cosmetic Act (PDF – 85KB) Final Guidance 5/1/1998 Modernization Act Standards for Prompt Review of Efficacy Supplements _Guidance (PDF – 76KB) Final Guidance 5/15/1998 Clinical/Medical Submission of Abbreviated Reports and Synopses in Support of Marketing Applications. (PDF – 43KB) Final Guidance 8/1/1999 Over-the-Counter Enforcement Policy on Marketing OTC Combination Products (CPG 7132b.16). (PDF – 294KB) Final Guidance 5/1/1984 Over-the-Counter General Guidelines for OTC Combination Products (PDF – 270KB) Final Guidance 11/1/1978 Over-the-Counter Label Comprehension Studies for Nonprescription Drug Products (PDF – 148KB) Final Guidance 8/3/2010 Over-the-Counter Labeling OTC Human Drug Products — Questions and Answers (PDF – 599KB) Final Guidance 1/2/2009 Over-the-Counter; Small Entity Compliance Guides Labeling OTC Human Drug Products; Small Entity Compliance Guide (PDF – 270KB) Final Guidance 5/12/2009 Over-the-Counter Labeling OTC Human Drug Products Updating Labeling in RLDs and ANDAs (PDF – 30KB) Final Guidance 10/1/2002 Over-the-Counter Labeling OTC Human Drug Products Using a Column Format (PDF – 57KB) Final Guidance 12/1/2000 Over-the-Counter Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application (PDF – 298KB) Final Guidance 7/13/2009 Over-the-Counter Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and Answers (PDF – 119KB) Final Guidance 9/19/2018 Over-the-Counter Time and Extent Applications for Nonprescription Drug Products (PDF – 241KB) Final Guidance 9/28/2011 Over-the-Counter Upgrading Category III Antiperspirants to Category I (43 FR 46728-46731) (PDF – 583KB) Final Guidance 10/1/1978 Over-the-Counter Self-Selection Studies for Nonprescription Drug Products (PDF – 160KB) Final Guidance 4/10/2013 Over-the-Counter; Small Entity Compliance Guide Labeling for Bronchodilators: Cold, Cough, Allergy, Bronchodilator, And Antiasthmatic Drug Products for Over-the-Counter Human Use (Small Entity Compliance Guide) Final Guidance. Updated for 508 compliance 11/14/2012 Over-the-counter Labeling and Effectiveness Testing: Sunscreen Drug Products for Over-The-Counter Human Use — Small Entity Compliance Guide Final Guidance 12/5/2012 Pharmaceutical Quality/CGMP; Compliance; Over-the-Counter Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use — (PDF – 173KB) Final Guidance 11/16/2015 Over-The-Counter Nonprescription Sunscreen Drug Products – Safety and Effectiveness Data (PDF – 140KB) Final Guridance 11/22/2016 Over-The-Counter Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending Request Guidance for Industry (PDF – 105KB) Final Guidance 10/7/2016 Over-the-Counter Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process (PDF – 103KB) Final Guidance 10/7/2016 Over-The-Counter Nonprescription Sunscreen Drug Products – Format and Content of Data Submissions (PDF – 117KB) Final Guidance 11/22/2016 Over-the-Counter; Small Entity Compliance Guides Consumer Antiseptic Wash Final Rule Questions and Answers (PDF – 92KB) Final Guidance 7/25/2017 Over-the-Counter Innovative Approaches for Nonprescription Drug Products (PDF – 247KB) Draft Guidance 7/17/2018 Pharmaceutical Quality/CMC Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products (PDF – 230KB) Draft Guidance 4/22/2016 Pharmaceutical Quality/CMC Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products (PDF – 33KB) Final Guidance 7/1/1997 Pharmaceutical Quality/CMC Changes to an Approved NDA or ANDA (PDF – 173KB) Final Guidance 4/1/2004 Pharmaceutical Quality/CMC Changes to an Approved NDA or ANDA: Questions and Answers (PDF – 35KB) Final Guidance 1/1/2001 Pharmaceutical Quality/CMC Changes to an Approved NDA or ANDA; Specifications – Use of Enforcement Discretion for Compendial Changes (PDF – 24KB) Final Guidance 11/19/2004 Pharmaceutical Quality/CMC CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports (PDF – 106KB) Final Guidance 3/4/2014 Pharmaceutical Quality/CMC Comparability Protocols — Chemistry, Manufacturing, and Controls Information (PDF – 195KB) Draft Guidance 2/25/2003 Pharmaceutical Quality/CMC Container Closure Systems for Packaging Human Drugs and Biologics (PDF – 164KB) Final Guidance 5/1/1999 Pharmaceutical Quality/CMC Container Closure Systems for Packaging Human Drugs and Biologics — Questions and Answers (PDF – 34KB) Final Guidance 5/1/2002 Pharmaceutical Quality/CMC Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived Products Final Guidance 4/1/1996 Pharmaceutical Quality/CMC Development of New Stereoisomeric Drugs Final Guidance 5/1/1992 Pharmaceutical Quality/CMC Drug Master Files: Guidelines Final Guidance 9/1/1989 Pharmaceutical Quality/CMC Drug Master Files for Bulk Antibiotic Drug Substances (PDF – 23KB) Final Guidance 11/1/1999 Pharmaceutical Quality/CMC Environmental Assessment of Human Drug and Biologics Applications (PDF – 188KB) Final Guidance 7/1/1998 Pharmaceutical Quality/CMC Format and Content for the CMC Section of an Annual Report (PDF – 29KB) Final Guidance 9/1/1994 Pharmaceutical Quality/CMC Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting Final Guidance 10/11/2011 Pharmaceutical Quality/CMC INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, and Controls Information (PDF – 283KB) Final Guidance 5/20/2003 Pharmaceutical Quality/CMC IND Meetings for Human Drugs and Biologics Chemistry, Manufacturing, and Controls Information (PDF – 30KB) Final Guidance 5/1/2001 Pharmaceutical Quality/CMC Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations (PDF – 88KB) Final Guidance 4/1/2014 Pharmaceutical Quality/CMC Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation (PDF – 120KB) Final Guidance 4/4/2018 Pharmaceutical Quality/CMC Monoclonal Antibodies Used as Reagents in Drug Manufacturing (PDF – 29KB) Final Guidance 3/1/2001 Pharmaceutical Quality/CMC Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products–Quality Considerations (PDF – 449KB) Draft Guidance (Revised) 4/18/2018 Pharmaceutical Quality/CMC Nasal Spray and Inhalation Solution, Suspension, and Drug Products (PDF – 285KB) Final Guidance 7/1/2002 Pharmaceutical Quality/CMC NDAs: Impurities in Drug Substances (PDF – 11KB) Final Guidance 2/1/2000 Pharmaceutical Quality/CMC Orally Disintegrating Tablets (PDF – 52KB) Final Guidance 12/17/2008 Pharmaceutical Quality/CMC PAC-ATLS: Postapproval Changes – Analytical Testing Laboratory Sites (PDF – 76KB) Final Guidance 4/28/1998 Pharmaceutical Quality/CMC Regulatory Classification of Pharmaceutical Co-Crystals (PDF – 87KB) Revised Final Guidance 2/14/2018 Pharmaceutical Quality/CMC Residual Drug in Transdermal and Related Drug Delivery Systems (PDF – 44KB) Final Guidance 8/16/2011 Pharmaceutical Quality/CMC Residual Solvents in Drug Products Marketed in the United States (PDF – 52KB) Final Guidance 11/24/2009 Pharmaceutical Quality/CMC Reviewer Guidance, Validation of Chromatographic Methods (PDF – 703KB) Final Guidance 11/1/1994 Pharmaceutical Quality/CMC Size of Beads in Drug Products Labeled for Sprinkle. (PDF – 148KB) Final Guidance 5/2/2012 Pharmaceutical Quality/CMC SUPAC: Manufacturing Equipment Addendum (PDF – 213KB) Final Guidance 12/1/2014 Pharmaceutical Quality/CMC SUPAC-IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation (PDF – 60KB) Final Guidance 11/1/1995 Pharmaceutical Quality/CMC SUPAC-IR Questions and Answers about SUPAC-IR Guidance Final Guidance 2/18/1997 Pharmaceutical Quality/CMC SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation (PDF – 215KB) Final Guidance 10/6/1997 Pharmaceutical Quality/CMC SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation (PDF – 118KB) Final Guidance 5/1/1997 Pharmaceutical Quality/CMC Tablet Scoring:Nomenclature, Labeling, and Data for Evaluation (PDF – 56KB) Final Guidance 3/13/2013 Pharmaceutical Quality/CMC Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products Final Guidance 12/5/2012 Pharmaceutical Quality/CMC Analytical Procedures and Methods Validation for Drugs and Biologics (PDF – 134KB) Final Guidance 7/24/2015 Pharmaceutical Quality/CMC Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products (PDF – 77KB) Final Guidance 6/24/2015 Pharmaceutical Quality/CMC Immunogenicity-Related Considerations for Low Molecular Weight Heparin Guidance for Industry (PDF – 136KB) Final Guidance 2/18/2016 Pharmaceutical Quality/CMC Alternate Source of the Active Pharmaceutical Ingredient in Pending ANDAs (PDF – 14KB) Final Guidance 12/1/2000 Pharmaceutical Quality/CMC ANDAs:Pharmaceutical Solid Polymorphism: Chemistry, Manufacturing, and Controls Information (PDF – 110KB) Final Guidance 7/6/2007 Pharmaceutical Quality/CMC ANDAs: Impurities in Drug Substances (PDF – 136KB) Final Guidance 7/15/2009 Pharmaceutical Quality/CMC ANDAs: Impurities in Drug Products (PDF – 155KB) Final Guidance 11/26/2010 Pharmaceutical Quality/CMC ANDAs: Stability Testing of Drug Substances and Products (PDF – 30KB) Final Guidance 6/18/2013 Pharmaceutical Quality/CMC ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers (PDF – 124KB) Final Guidance 5/14/2014 Pharmaceutical Quality/CMC Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules (PDF – 89KB) Final Guidance 6/18/2015 Pharmaceutical Quality/CMC Guidance for Industry – Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products (PDF) (PDF – 64KB) Final Guidance 2/1/2008 Pharmaceutical Quality/CMC Development and Submission of Near Infrared Analytical Procedures (PDF – 176KB) Draft Guidance 3/30/2015 Pharmaceutical Quality/CMC Environmental Assessment: Questions and Answers Regarding Drugs With Estrogenic, Androgenic, or Thyroid Activity (PDF – 69KB) Final Guidance 3/4/2016 Pharmaceutical Quality/CMC Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products Guidance for Industry (PDF – 165KB) Draft Guidance 5/29/2015 Pharmaceutical Quality/CMC and Pharmaceutical Quality/CGMP Submission of Quality Metrics Data Guidance for Industry (PDF – 340KB) Draft Guidance 11/23/2016 Pharmaceutical Quality/CMC Botanical Drug Development: Guidance for Industry (PDF – 221KB) Final Guidance 12/28/2016 Pharmaceutical Quality/CMC Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use (PDF – 167KB) Final Guidance 10/2/2018 Pharmaceutical Quality/CMC Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization Guidance for Industry (PDF – 71KB) Final Guidance 9/28/2017 Pharmaceutical Quality/CMC Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information Guidance for Industry (PDF – 200KB) Draft Guidance 4/19/2016 Pharmaceutical Quality/CMC Quality Attribute Considerations for Chewable Tablets Guidance for Industry (PDF – 169KB) Final Guidance 8/20/2018 Pharmaceutical Quality/Manufacturing Standards (CGMP) Request for Quality Metrics. Technical Specifications Document: “Quality Metrics Technical Conformance Guide, Version 1.0“ has published (PDF – 114KB) Draft Guidance 6/24/2016 Pharmaceutical Quality/CMC Elemental Impurities in Drug Products Guidance for Industry (PDF – 92KB) Final Guidance 8/7/2018 Pharmaceutical Quality – CMC Regulatory Classification of Pharmaceutical Co-Crystals- Draft (PDF – 82KB) Draft Guidance 8/16/2016 Pharmaceutical Quality/CMC CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports (PDF – 93KB) Draft Guidance 8/8/2017 Pharmaceutical Quality / CMC Drug Products, Including Biological Products, that Contain Nanomaterials – Guidance for Industry (PDF – 235KB) Draft Guidance 12/15/2017 Pharmaceutical Quality/Manufacturing Standards (CGMP). and Pharmaceutical Quality/CMC. Field Alert Report Submission: Questions and Answers Guidance for Industry (PDF – 123KB) Draft Guidance 7/18/2018 Pharmaceutical Quality/CMC Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments (PDF – 410KB) Draft Guidance 7/24/2018 Pharmaceutical Quality/CMC Postapproval Changes to Drug Substances Guidance for Industry (PDF – 393KB) Draft guidance 9/10/2018 Pharmaceutical Quality/Manufacturing Standards (CGMP) COMPRESSED MEDICAL GASES GUIDELINE Final Guidance 2/1/1989 Compliance; Pharmaceutical Quality/Manufacturing Standards (CGMP) Contract Manufacturing Arrangements for Drugs: Quality Agreements (PDF – 123KB) Final Guidance 11/22/2016 Pharmaceutical Quality/Manufacturing Standards (CGMP) Current Good Manufacturing Practice for Medical Gases (PDF – 219KB) Draft Guidance 6/28/2017 Pharmaceutical Quality/Manufacturing Standards (CGMP) Current Good Manufacturing Practice for Phase 1 Investigational Drugs (PDF – 92KB) Final Guidance 7/14/2008 Pharmaceutical Quality/Manufacturing Standards (CGMP) Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron (PDF – 89KB) Final Guidance 6/27/1997 Pharmaceutical Quality/Manufacturing Standards (CGMP) Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products (PDF – 72KB) Draft Guidance 8/8/2017 Pharmaceutical Quality/Manufacturing Standards (CGMP) Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP_PRA (PDF – 66KB) Final Guidance 1/11/2006 Pharmaceutical Quality/Manufacturing Standards (CGMP) Guidance for Hospitals, Nursing Homes, and Other Health Care Facilities – FDA Public Health Advisory (PDF – 19KB) Final Guidance 4/5/2001 Pharmaceutical Quality/Manufacturing Standards (CGMP) Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality (PDF – 60KB) Final Guidance 6/25/2013 Pharmaceutical Quality/Manufacturing Standards (CGMP) Investigating Out-of-Specification Test Results for Pharmaceutical Production (PDF – 86KB) Final Guidance 10/11/2006 Pharmaceutical Quality/Manufacturing Standards (CGMP) Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography (PDF – 156KB) Final Guidance 4/10/2012 Pharmaceutical Quality/Manufacturing Standards (CGMP) Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination (PDF – 70KB) Final Guidance 4/17/2013 Pharmaceutical Quality/Manufacturing Standards (CGMP) PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (PDF – 211KB) Final Guidance 9/29/2004 Pharmaceutical Quality/Manufacturing Standards (CGMP) PET Drug Products – Current Good Manufacturing Practice (CGMP) (PDF – 399KB) Final Guidance 12/9/2009 Pharmaceutical Quality/Manufacturing Standards (CGMP) and Small Entity Compliance Guide PET Drugs–Current Good Manufacturing Practice (CGMP); Small Entity Compliance Guide (PDF – 229KB) Final Guidance 8/4/2011 Pharmaceutical Quality/Manufacturing Standards (CGMP) Pharmaceutical Components at Risk for Melamine Contamination (PDF – 137KB) Final Guidance 8/6/2009 Pharmaceutical Quality/Manufacturing Standards (CGMP) Possible Dioxin/PCB Contamination of Drug and Biological Products (PDF – 8KB) Final Guidance 8/23/1999 Pharmaceutical Quality/Manufacturing Standards (CGMP) Preparation of Investigational New Drug Products (Human and Animal) (PDF – 795KB) Final Guidance 11/1/1992 Pharmaceutical Quality/Manufacturing Standards (CGMP) Process Validation: General Principles and Practices (PDF – 372KB) FINAL Guidance 1/24/2011 Pharmaceutical Quality/Manufacturing Standards (CGMP) Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations (PDF – 363KB) Final Guidance 9/27/2006 Pharmaceutical Quality/Manufacturing Standards (CGMP) Questions and Answers on Current Good Manufacturing Practices for Drugs Final Guidance 12/21/2011 Pharmaceutical Quality/Manufacturing Standards (CGMP) Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice (PDF – 734KB) Final Guidance 9/29/2004 Pharmaceutical Quality/Manufacturing Standards (CGMP) Testing of Glycerin for Diethylene Glycol (PDF – 36KB) Final Guidance 5/1/2007 Pharmaceutical Quality/Manufacturing Standards (CGMP) The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 – Current Good Manufacturing Practice (CGMP) (PDF – 127KB) Final Guidance 1/26/2010 Pharmaceutical Quality/Manufacturing Standards (CGMP) Guidance for Industry: Pyrogen and Endotoxins Testing: Questions and Answers Final Guidance 6/28/2012 Compounding; Pharmaceutical Quality/Manufacturing Standards (CGMP) Current Good Manufacturing Practice Requirements for Combination Products   1/10/2017 Pharmaceutical Quality/Microbiology Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products (PDF – 57KB) Final Guidance 11/1/1994 Pharmaceutical Quality/Microbiology Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes (PDF – 73KB) Final Guidance 2/25/2010 Pharmaceutical Quality/Microbiology Format and Content of the Microbiology Section of an Application* (PDF – 546KB) Final Guidance 1/1/1990 Pharmacology / Toxicology Carcinogenicity Study Protocol Submissions (PDF – 29KB) Final Guidance 5/22/2002 Clinical/Medical; Investigational New Drug Applications; Pharmacology/Toxicology Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products (PDF – 42KB) Final Guidance 11/1/1995 Pharmacology / Toxicology Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers (PDF – 702KB) Final Guidance 7/28/2005 Investigational New Drug Applications Exploratory IND Studies (PDF – 220KB) Final Guidance 1/12/2006 Pharmacology / Toxicology Format and Content of the Nonclinical Pharmacology/Toxicology Section of an Application* (PDF – 1.3MB) Final Guidance 2/1/1987 Pharmacology / Toxicology Immunotoxicology Evaluation of Investigational New Drugs (PDF – 100KB) Final Guidance 10/1/2002 Pharmacology / Toxicology Reproductive and Developmental Toxicities — Integrating Study Results to Assess Concerns (PDF – 392KB) Final Guidance 9/22/2011 Pharmacology / Toxicology Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals (PDF – 137KB) Final Guidance 11/25/2011 Pharmacology / Toxicology Nonclinical Pharmacology/Toxicology Development of Topical Drugs Intended to Prevent the Transmission of Sexually Transmitted Diseases (STD) and/or for the Development of Drugs Intended to Act as Vaginal Contraceptives Final Guidance 7/1/2005 Pharmacology / Toxicology Nonclinical Safety Evaluation of Drug or Biologic Combinations (PDF – 100KB) Final Guidance 3/15/2006 Pharmacology / Toxicology Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route (PDF – 153KB) Final Guidance 10/27/2015 Pharmacology / Toxicology Nonclinical Safety Evaluation of Pediatric Drug Products (PDF – 479KB) Final Guidance 2/15/2006 Pharmacology / Toxicology Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients (PDF – 230KB) Final Guidance 5/18/2005 Pharmacology / Toxicology Recommended Approaches to Integration of Genetic Toxicology Study Results (PDF – 190KB) Final Guidance 1/3/2006 Pharmacology / Toxicology Reference Guide for the Nonclinical Toxicity Studies of Antivial Drugs Indicated for the Treatment of N/A Non-Life Threatening Disease Evaluation of Drug Toxicity Prior to Phase I Clinical Studies (PDF – 837KB) Final Guidance 3/2/1998 Pharmacology / Toxicology Safety Testing of Drug Metabolites (PDF – 185KB) Final Guidance 11/22/2016 Pharmacology / Toxicology Single Dose Acute Toxicity Testing for Pharmaceuticals (PDF – 63KB) Final Guidance 8/1/1996 Pharmacology / Toxicology ; Biostatistics Statistical Aspects of the Design, Analysis, and Interpretation of Chronic Rodent Carcinogenicity Studies of Pharmaceuticals (PDF – 135KB) Draft Guidance 5/8/2001 Pharmacology / Toxicology Nonclinical Evaluation of Endocrine-Related Drug Toxicity (PDF – 129KB) Final Guidance 9/8/2015 Pharmacology/Toxicology Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment (PDF – 179KB) Draft Guidance 5/12/2015 Pharmacology/Toxicology Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment Guidance for Industry (PDF – 146KB) Draft Guidance 6/13/2016 Pharmacology/Toxicology Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations (PDF – 83KB) Final Guidance 8/20/2018 Pharmacology / Toxicology Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations Guidance for Industry (PDF – 122KB) Draft Guidance 9/28/2017 Pharmacology / Toxicology Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations Guidance for Industry Draft Guidance 6/28/2018 Pharmacology / Toxicology Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products Draft guidance 8/3/2018 Procedural 180-Day Generic Drug Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (PDF – 77KB) Final Guidance 6/1/1998 Procedural Applications Covered by Section 505(b)(2) (PDF – 41KB) Draft Guidance 12/8/1999 Procedural Certification Process of Designated Medical Gases (PDF – 279KB) Draft Guidance, Revised 11/24/2015 Procedural Charging for Investigational Drugs Under an IND — Qs & As (PDF – 87KB) Final Guidance 6/2/2016 Procedural Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act (PDF – 136KB) Final Guidance 11/18/2014 Procedural Complementary and Alternative Medicine Products and their Regulation by the Food and Drug Administration Draft Guidance 12/1/2006 Procedural Dear Health Care Provider Letters: Improving Communication of Important Safety Information (PDF – 128KB) Final Guidance 2/8/2017 Procedural Disclosure of Materials Provided to Advisory Committees in Connection with Open Advisory Committee Meetings Convened by the Center for Drug Evaluation and Research Beginning on January 1, 2000 (PDF – 10KB) Final Guidance 11/1/1999 Procedural Drug Products Containing Ensulizole, Hypromellose, Meradimate, Octinoxate, and Octisalate — Labeling Enforcement Policy (PDF – 159KB) Final Guidance 6/3/2003 Procedural Emergency Use Authorization of Medical Products and Related Authorities Draft Guidance, published April 2016 1/13/2017 Procedural End-of-Phase 2A Meetings (PDF – 163KB) Final Guidance 9/18/2009 Procedural Expedited Programs for Serious Conditions––Drugs and Biologics (PDF – 160KB) Final Guidance 9/22/2017 Procedural Expanded Access to Investigational Drugs for Treatment Use — Qs & As (PDF – 253KB) Final Guidance 10/3/2017 Guidance for Industry – FDA Export Certificates FDA Export Certificates Final Guidance 7/12/2004 Procedural FDA Oversight of PET Drug Products — Questions and Answers (PDF – 499KB) Final Guidance 12/3/2012 Procedural Fixed Dose Combinations, Co-Packaged Drug Products, and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment of HIV (PDF – 343KB) Final Guidance 10/17/2006 Procedural Formal Dispute Resolution: Appeals Above the Division Level Guidance for Industy (PDF – 214KB) Final Guidance 11/3/2017 Procedural Guidance Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices Final Guidance 1/1/2009 Procedural Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications (PDF – 98KB) Revised Draft Guidance 9/24/2018 Procedural Guidance for Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting to IRBs — Improving Human Subject Protection (PDF – 61KB) Final Guidance 1/14/2009 Subject Withdrawal – Guidance Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials (PDF – 75KB)   10/1/2008 Procedural How to Comply with the Pediatric Research Equity Act (PDF – 116KB) Draft Guidance 9/7/2005 Procedural Independent Consultants for Biotechnology Clinical Trial Protocols Final Guidance 8/1/2004 User Fees Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act (PDF – 27KB) Final Guidance 11/1/2001 Procedural Financial Disclosure by Clinical Investigators (PDF – 165KB)   2/1/2013 Procedural Frequently Asked Questions – Statement of Investigator (Form FDA 1572) – Information Sheet (PDF – 105KB) Final Guidance 5/1/2010 Procedural Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document (PDF – 98KB) Final Guidance 4/20/2009 Procedural Integrated Summary of Effectiveness (PDF – 274KB) Final Guidance 10/7/2015 Procedural Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects (PDF – 163KB) Final Guidance 10/23/2009 Procedural Levothyroxine Sodium Products Enforcement of August 14, 2001 Compliance Date and Submission of New Applications (PDF – 24KB) Final Guidance 7/1/2001 Procedural Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring (PDF – 163KB) Final Guidance 8/6/2013 Procedural Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans (PDF – 408KB) Draft Guidance 3/8/2016 Procedural; Modernization Act PET Drug Applications – Content and Format for NDAs and ANDAs_2011 (PDF – 429KB) Final Guidance 8/31/2011 Procedural Positron Emission Tomography (PET) Drug SPL   1/2011 Procedural Pharmacogenomic Data Submissions (PDF – 307KB) Final Guidance 3/1/2005 Procedural Pharmacogenomic Data Submissions; Examples of Voluntary Submissions or Submissions Required Under 21 CFR 312, 314, or 601 (PDF – 63KB) Final Guidance 3/1/2005 Procedural Pharmacogenomic Data Submissions — Companion Guidance (PDF – 211KB) Draft Guidance 8/28/2007 Procedural Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines (PDF – 375KB) Draft Guidance 3/12/2001 Procedural Potassium Iodide as a Thyroid Blocking Agent in Radiation Emergencies (PDF – 40KB) Final Guidance 12/10/2001 Procedural (Potassium Iodide) KI in Radiation Emergencies-Questions and Answers (PDF – 161KB) Final Guidance 12/23/2002 Procedural Potassium Iodide Tablets – Shelf Life Extension (PDF – 191KB) Final Guidance 3/8/2004 Procedural Guidance for Clinical Investigators, Institutional Review Boards and Sponsors – Process for Handling Referrals to FDA Under 21 CFR 50.54 – Additional Safeguards for Children in Clinical Investigations (PDF) (PDF – 116KB)   12/1/2006 Modernization Act Reports on the Status of Postmarketing Study Commitments — Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 (PDF – 456KB) Final Guidance 2/15/2006 Procedural Standards for Securing the Drug Supply Chain – Standardized Numerical Identification for Prescription Drug Packages   3/1/2010 Procedural Submitting and Reviewing Complete Responses to Clinical Holds (Revised) (PDF – 26KB) Final Guidance 10/1/2000 Procedural Submitting Debarment Certification Statements (PDF – 144KB) Draft Guidance 10/2/1998 Procedural Submitting Marketing Applications According to the ICH/CTD Format: General Considerations 2001 (PDF – 50KB) Draft Guidance 9/5/2001 Procedural Target Product Profile — A Strategic Development Process Tool (PDF – 454KB) Draft Guidance 3/30/2007 Procedural Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products (PDF – 153KB) Draft Guidance 6/6/2013 Procedural Toll-Free Number Labeling and Related Requirements for Over-the-Counter and Prescription Drugs Marketed With Approved Applications (PDF – 119KB) Final Guidance 6/14/2012 Procedural Tropical Disease Priority Review Vouchers (PDF – 193KB) Final Guidance 10/5/2016 Procedural Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification Guidance for Industry (PDF – 126KB) Final Guidance 5/13/2016 Procedural Useful Written Consumer Medication Information (CMI) (PDF – 278KB) Final Guidance 7/17/2006 Procedural Using a Centralized IRB Review Process in Multicenter Clinical Trials (PDF – 87KB) Final Guidance 3/15/2006 Procedural Women and Minorities Guidance Requirements (PDF – 30KB) Final Guidance 7/20/1998 Procedural Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices (PDF – 302KB) Draft Guidance 12/27/2011 Modernization Act; Procedural National Uniformity for Nonpresciption Drugs – Ingredient Listing for OTC Drugs (PDF – 74KB) Final Guidance 4/1/1998 Procedural IRB Continuing Review After Clinical Investigation Approval (PDF – 145KB)   2/1/2012 Procedural Electronic Source Data in Clinical Investigations (PDF – 190KB) Final Guidance 9/17/2013 Procedural Pre-Launch Activities Importation Requests (PLAIR) (PDF – 180KB) Draft Guidance 7/24/2013 Procedural Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration (PDF – 183KB) Draft Guidance 9/4/2013 Procedural Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices – Revised Guidance (PDF – 150KB) Draft Guidance – Revised 2/28/2014 Procedural Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products—Recommended Practices (PDF – 95KB) Draft Guidance 6/6/2014 Procedural Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification Guidance for Industry (PDF – 146KB) Final Guidance 12/8/2016 Procedural; Biosimilars Reference Product Exclusivity for Biological Products Filed Under (PDF – 99KB) Draft Guidance 8/4/2014 Procedural FDA’s guidance on uniform national policy (Section 585 of the FD&C Act) (PDF – 155KB) Draft Guidance 10/7/2014 Procedural Critical Path Innovation Meetings (PDF – 68KB) Final Guidance 3/30/2015 Procedural New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products (PDF – 351KB) Final Guidance 10/10/2014 Procedural Specification of the Unique Facility Identifier (UFI) System for Drug Establishment (PDF – 61KB) Final Guidance 11/5/2014 Procedural DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information (PDF – 85KB) Draft Guidance 11/26/2014 Procedural DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers (PDF – 94KB) Draft Guidance 12/8/2014 Procedural DSCSA Implementation: Product Tracing Requirements — Compliance Policy (PDF – 56KB) Final Guidance 12/23/2014 Procedural Individual Patient Expanded Access Applications: Form FDA 3926 (PDF – 356KB) Final Guidance 10/3/2017 Procedural Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers (PDF – 231KB) Final Guidance 12/14/2016 Procedural Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators (PDF – 431KB) Draft Guidance 5/14/2015 Compounding; Procedural Guidance For Entities Considering Whether to Register As Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF – 74KB) Final Guidance 8/11/2015 Compounding; Procedural Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF – 71KB) Final Guidance 11/21/2014 Procedural DSCSA Implementation: Product Tracing Requirements for Dispensers — Compliance Policy (Revised) Guidance for Industry (PDF – 55KB) Final Guidance 10/28/2015 Compounding; Procedural Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance (PDF – 85KB) Final Guidance 6/9/2016 Compounding; Procedural Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF – 112KB) Revised Final Guidance 1/13/2017 Procedural Best Practices for Communication Between IND Sponsors and FDA During Drug Development (PDF – 191KB) Final Guidance 12/28/2017 Procedural Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic Act— Compliance Policy Guidance for Industry (PDF – 89KB) Final guidance 2/16/2017 Procedural Special Protocol Assessment Guidance for Industry (PDF – 182KB) Final Guidance 4/12/2018 Procedural Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers Guidance for Industry (PDF – 111KB) Draft Guidance 1/9/2017 Procedural Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers Guidance for Industry (PDF – 163KB) Final Guidance 6/12/2018 Procedural Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers Guidance for Industry and Review Staff (PDF – 294KB) Final Guidance 6/12/2018 Procedural Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – (PDF – 240KB) Draft Guidance 6/20/2017 Procedural Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy Guidance for Industry (PDF – 254KB) Final guidance 9/19/2018 Procedural Identifying Trading Partners Under the Drug Supply Chain Security Act Guidance for Industry (PDF – 181KB) Draft Guidance 8/18/2017 Procedural Use of a Drug Master File for Shared System REMS Submissions Guidance for Industry (PDF – 103KB) Draft Guidance 11/8/2017 Procedural Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier (PDF – 319KB) Final Guidance 9/19/2018 Procedural Refuse to File: NDA and BLA Submissions to CDER Guidance for Industry (PDF – 109KB) Draft Guidance 12/12/2017 Procedural Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products Guidance for Industry (PDF – 156KB) Draft Guidance 12/28/2017 Procedural Qualified Infectious Disease Product Designation Questions and Answers (PDF – 390KB) Draft Guidance 1/29/2018 Procedural Standardization of Data and Documentation Practices for Product Tracing Guidance for Industry (PDF – 170KB) Draft Guidance 2/28/2018 Procedural Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act Guidance for Industry (PDF – 283KB) Draft Guidance 2/28/2018 Procedural Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination Guidance for Industry (PDF – 68KB) Draft Guidance 4/12/2018 Procedural Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF – 117KB) Draft Guidance 5/8/2018 Procedural Patient-Focused Drug Development: Collecting Comprehensive and Representative Input (PDF – 545KB) Draft Guidance 6/12/2018 Procedural Limited Population Pathway for Antibacterial and Antifungal Drugs Guidance for Industry (PDF – 128KB) Draft Guidance 6/12/2018 Procedural Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry (PDF – 145KB) Draft guidance 8/10/2018 Procedural Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry (PDF – 479KB) Draft Guidance 9/28/2018 Procedural Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications Guidance for Industry and FDA Staff (PDF – 457KB) Draft Guidance 9/28/2018 Procedural Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act. (PDF – 194KB) Draft Guidance (revised final) 10/2/2018 Procedural Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs Guidance for Industry (PDF – 357KB) Draft Guidance 10/24/2018 Product-Specific Guidances for Generic Drug Development       Rare Diseases Rare Pediatric Disease Priority Review Vouchers, Draft Guidance for Industry   11/17/2014 Rare Diseases Rare Diseases: Common Issues in Drug Development Guidance for Industry (PDF – 306KB) Draft Guidance 8/14/2015 Rare Diseases Pediatric Rare Diseases–A Collaborative Approach for Drug Development Using Gaucher Disease as a Model; Draft Guidance for Industry (PDF – 262KB) Draft Guidance 12/6/2017 Rare Diseases Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition That Results from Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies Guidance for Industry (PDF – 111KB) Draft guidance 7/26/2018 Rare Diseases Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings Guidance for Industry (PDF – 132KB) Draft Guidance 10/15/2018 Procedural / RWD/RWE Use of Electronic Health Record Data in Clinical Investigations Guidance for Industry (PDF – 327KB) Final Guidance 7/18/2018 Small Entity Compliance Guides Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation — Small Entity Compliance Guide (PDF – 18KB) Final Guidance 11/7/2001 Over-the-Counter; Small Entity Compliance Guides Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use — Small Entity Compliance Guide (PDF – 176KB) Final Guidance 8/17/2010 Labeling; Small Entity Compliance Guides Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry (Small Entity Compliance Guide) (PDF – 165KB) Final Guidance 6/10/2015 Small Entity Compliance Guides 2016 Medical Gas Container-Closure Rule Questions and Answers Guidance for Industry (PDF – 82KB) Final guidance 1/17/2017 User Fees User Fee Waivers, Reductions, and Refunds for Drug and Biological Products (PDF – 153KB) Final Guidance 1/6/2015 User Fees Fees-Exceed-the-Costs Waivers Under the Prescription Drug User Fee Act (PDF – 48KB) Final Guidance 6/1/1999 Guidance for Industry and FDA Staff – Application User Fees for Combination Products (PDF) Guidance for Industry and FDA Staff – Application User Fees for Combination Products (PDF) (PDF – 83KB)   4/1/2005 User Fees Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees (PDF – 211KB) Final Guidance 12/30/2004 User Fees User Fee Waivers for FDC and Co-Packaged HIV Drugs for PEPFAR (PDF – 46KB) Final Guidance 2/7/2007 User Fees; Generics Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments (PDF – 222KB) Final Guidance 11/21/2016 Generics; User Fees Controlled Correspondence Related to Generic Drug Development (PDF – 379KB) Final Guidance 9/28/2015 Generics; User Fees ANDA Submissions — Amendments to Abbreviated New Drug Applications Under GDUFA (PDF – 219KB) Final Guidance 7/3/2018 Generics; User Fees ANDA Submissions — Refuse-to-Receive Standards Rev.2 (PDF – 199KB) Final Guidance 12/21/2016 Generics; User Fees ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin Guidance for Industry (PDF – 105KB) Draft Guidance 10/2/2017 Generics; User Fees Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA Guidance for Industry (PDF – 154KB) Draft Guidance 10/2/2017 Generics; User Fees ANDA Submissions – Refuse-to-Receive Standards: : Questions and Answers Guidance for Industry (PDF – 153KB) Draft Guidance 10/2/2017 Generics; User Fees Requests for Reconsideration at the Division Level Under GDUFA Guidance for Industry (PDF – 99KB) Draft Guidance 10/11/2017 User Fees Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017 Guidance for Industry (PDF – 145KB) Final Guidance 5/2/2018 User Fees Assessing User Fees Under the Biosimilar User Fee Amendments of 2017 Guidance for Industry (PDF – 447KB) Final Guidance 6/28/2018 User Fees Prescription Drug User Fee Act Waivers for Fixed-Combination Antiretroviral Drugs for the President’s Emergency Plan for AIDS Relief (PDF – 332KB) Draft Guidance 6/6/2018 User Fees Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products Guidance for Industry (PDF – 632KB) Draft Guidance 6/20/2018

http://www.fda.gov/drugs/guidances-drugs/all-guidances-drugs

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