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Gottlieb to Tackle Drug Prices at AEI

Departing FDA commissioner Scott Gottlieb tells the Washington Post he will be returning to the American Enterprise Institute to study ways to reduce ...

Animal Drugs

FDA Releases Animal Product Adverse Reports

FDA says it is releasing 30 years of animal medical product adverse events reports and will update the online database quarterly.

Human Drugs

Groups Want Old Mifeprex Labeling Restored

Two pro-life medical groups ask FDA to return Mifeprex labeling to its 2000 provisions, overturning changes made in 2016.

Human Drugs

FDA Authorizes 1st Parallel REMS

Attorney Sara Koblitz says FDA approved a parallel REMS system for one of four generic manufacturers of Gileads Letairis.

Federal Register

Hearing on Developing Affordable Insulin Products

Federal Register notice: FDA announces a 5/13 public hearing to discuss access to affordable insulin products and issues related to the development an...

Federal Register

ChlorTrimeton Not Withdrawn Due to Safety/Efficacy

Federal Register notice: FDA determines that Bayers ChlorTrimeton Allergy 12 Hour (chlorpheniramine maleate) extended release tablets 8mg and 12mg wer...

Federal Register

Onfi Not Withdrawn Due to Safety/Efficacy: FDA

Federal Register notice: FDA determines that Lundbeck Pharmaceuticals Onfi (clobazam) tablets 5mg were not withdrawn from sale for reasons of safety o...

Federal Register

Electronic Product Radiation Safety Panel Renewal

Federal Register notice: FDA announces the renewal of the Technical Electronic Product Radiation Safety Standards Committee for an additional two year...

Human Drugs

Praise, Suggestions for Draft REMS Guidance

Diverse stakeholders praise FDA for its draft guidance on REMS assessment and evaluation and offer recommendations for changes to be made to the docum...

Medical Devices

O-Two Medical Recalls Automatic Transport Ventilators

O-Two Medical Technologies recalls its e700, e600 and e500 Automatic Transport Ventilators because an improperly inserted screw in the ventilator scre...