FDA and HHS withdraw a policy statement on drug review transparency that was issued in the final days of the previous administration.
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...
Pacific Medical Group recalls the Alaris Infusion Pump Module Model 8100 Front Bezel because components may crack or separate.
FDA issues Leo Pharma a complete response letter for tralokinumab and its use in adults with moderate-to-severe atopic dermatitis.
Federal Register notice: FDA seeks comments on an information collection revision entitled Human Drug Compounding, Repackaging, and Related Activities...
FDA sends Biogen a complete response letter on its sBLA for a new Tysabri route of administration.
AdvaMedDx sends FDA recommendations for changes to an agency guidance on evaluating the impact of viral mutations on Covid-19 tests.
Federal Register notice: FDA seeks comments on an information collection extension entitled Establishment and Operation of Clinical Trial Data Monitor...