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Federal Register

Info Collection on Rx Drug Advertising

Federal Register notice: FDA seeks comments on an information collection extension entitled Prescription Drug Advertising 21 CFR Part 202.

Federal Register

Updated List of Device Consensus Standards

Federal Register notice: FDA announces a publication containing modifications to its list of standards FDA recognizes for use in premarket reviews.

Human Drugs

FDA/HHS Withdraw Trump Policy on Drug Stats

FDA and HHS withdraw a policy statement on drug review transparency that was issued in the final days of the previous administration.

Human Drugs

2 Bills Introduced to Speed Generic Drugs

U.S. senators Bill Cassidy (R-LA) and Tina Smith (D-MN) introduce two bills with the stated purpose of speeding the development of and improving acces...

Medical Devices

Pacific Medical Recalls Alaris Pump Front Bezel

Pacific Medical Group recalls the Alaris Infusion Pump Module Model 8100 Front Bezel because components may crack or separate.

Human Drugs

Leo Dermatitis Drug Gets Complete Response

FDA issues Leo Pharma a complete response letter for tralokinumab and its use in adults with moderate-to-severe atopic dermatitis.

Federal Register

Info Collection on Drug Compounding

Federal Register notice: FDA seeks comments on an information collection revision entitled Human Drug Compounding, Repackaging, and Related Activities...

Human Drugs

FDA Unable to Approve Tysabri sBLA

FDA sends Biogen a complete response letter on its sBLA for a new Tysabri route of administration.

Medical Devices

AdvaMedDx Comments on FDA Viral Mutation Impact Guidance

AdvaMedDx sends FDA recommendations for changes to an agency guidance on evaluating the impact of viral mutations on Covid-19 tests.

Federal Register

Data Monitoring Committee Info Collection

Federal Register notice: FDA seeks comments on an information collection extension entitled Establishment and Operation of Clinical Trial Data Monitor...