Monthly ArchiveJune 2019

Fecal Microbiota for Transplantation: Safety Communication- Risk of Serious Adverse Reactions Due to Transmission of Multi-Drug Resistant Organisms

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FDA MedWatch Alert regarding Fecal Microbiota for Transplantation: Safety Communication- Risk of Serious Adverse Reactions Due to Transmission of Multi-Drug Resistant Organisms …

Pharmacy Compounding Advisory Committee Roster

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This page contains the PCAC roster, which lists the current members and the current number of vacancies for the committee. …

Dean Obeidallah Wins $4.1M In Defamation Suit Against Neo-Nazi Website

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NPR’s Michel Martin speaks with comedian Dean Obeidallah, who this week was awarded $4.1 million in damages for defamation from the neo-Nazi website, The Daily Stormer. …

Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act

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Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act …

Product Development Under the Animal Rule

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Animal Rule …

Drug Master Files (DMFs)

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Info helps to master FDA’s list of Drug Master Files (DMFs) and info on submission of DMFs to agency. FDA provides info on DMF list, status of DMF, types of DMF, and more. …

Endocrinologic and Metabolic Drugs Advisory Committee Roster

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Advisory Committees (Drugs) …

Opioid Maker Insys Admits To Bribing Doctors, Agrees To Pay $225 Million Settlement

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The company agreed to make the payments to resolve federal criminal and civil investigations of its marketing practices. Five of its executives were convicted separately for the same practices. …

IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed

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IRB Responsibilities related to investigator qualifications, site adequacy, and whether an IND/IDE is needed – guidance …

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