Federal Register notice: FDA seeks comments on an information collection extension entitled Prescription Drug Advertising 21 CFR Part 202.
Federal Register notice: FDA announces a publication containing modifications to its list of standards FDA recognizes for use in premarket reviews.
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.