Monthly ArchiveMay 2019

TeraPharm – 111111 – 10/09/2018

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Finished Pharmaceuticals/Unapproved New Drug/Misbranded …

Informed Consent

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Informed Consent Information Sheet – Draft Guidance …

FDA approves ruxolitinib for acute graft-versus-host disease

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On May 24, 2019, the Food and Drug Administration approved ruxolitinib (JAKAFI®, Incyte Corporation) for steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older. …

As Opioids Fuel Growing Female Prison Population, Ohio Tries Alternative Treatment

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Ohio’s growing female prison population can be tied to drugs and addiction. Officials want to stop the cycle. One program helps women get at the root of their problems to help them change. …

Drug Safety and Risk Management Advisory Committee Roster

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

Biomarker Qualification Submissions

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The FDA CDER Biomarker Qualification Program invites submitters who have a biomarker qualification project accepted into the Program to voluntarily provide general information about their project and contact information to be posted on the FDA’s public web site. The table below lists submissions that are currently in the qualification process. Submissions listed here are only for those which submitters have agreed to make public. The table is updated on a quarterly basis and provides information on the biomarker qualification project and submitter contact information. …

May 7, 2019: Meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting Announcement – 05/07/2019 – 05/07/2019

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May 7, 2019: Meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting Announcement …

FY 2019 Generic Drug Regulatory Science Initiatives Public Workshop – 05/01/2019 – 05/01/2019

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FDA will hold a public workshop that will provide an overview of the current status of the regulatory science initiatives for generic drugs and will provide an opportunity for public input on research priorities in these topic areas. FDA is seeking input from a variety of stakeholders––industry, academia, patient advocates, professional societies, …

Trump Pardons His Friend Conrad Black, Who Wrote Glowing Trump Biography Last Year

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The former media mogul was convicted of fraud in 2007 and served more than 3 years in prison. Black says Trump told him he was reversing an unjust verdict, not rewarding him for his support. …

Drug Alerts and Statements

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FDA Drug Alerts and Statements …

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