An online CBER report describes Center collaborative efforts with international partners on Covid-19.
Attorney Marc Ullman argues against a proposal for mandatory dietary supplement listing with FDA as a way to improve agency enforcement.
The Justice Department says a Florida man pleaded guilty to one count of conspiracy to violate the anti-kickback law through a compounded drug scheme.
FDA grants Bavarian Nordic A/S a breakthrough therapy designation for vaccine candidate MVA-BN RSV for preventing lower respiratory tract disease.
FDA gives Regenerative Medicine Advanced Therapy designation to a University of California San Francisco gene therapy treatment for Artemis-SCID disea...
Federal Register notice: FDA announces a 3/10 Cellular, Tissue, and Gene Therapies Advisory Committee meeting to hear an overview of research programs...
Federal Register notice: FDA seeks industry organizations to help in selecting voting industry representatives to serve on CDRHs Technical Electronic ...
Two Dechert attorneys say businesses accounting for off-label uses of a drug or medical device when deciding how much to produce need not run afoul of...