Timothy Schell leaves industry to return to FDA to lead CVMs the Office of Surveillance and Compliance.
CBER issues a guidance to help biological product manufacturers submit lot release protocols in electronic format.
The Office of Generic Drugs annual report shows that 1,021 ANDAs were approved or tentatively approved in 2018.
Federal Register notice: FDA announces a 3/19-20 meeting of the National Center for Toxicological Researchs Science Advisory Board.
CDRH says it is evaluating whether any medical device supply issues will result from the closing of the Sterigenics Willowbrook, IL, product steriliza...
FDA clears a Medtronic 510(k) for the Accurian RF ablation platform for use in radio frequency ablation of nerve tissues.
Bayer completes submission of a rolling NDA for its investigational prostate cancer drug darolutamide.
FDA issues Adamis Pharmaceuticals a Refusal to File letter on an NDA for its sublingual tadalafil product, indicated for treating erectile dysfunction...