CDER special assistant for labeling Iris Masucci uses a Webinar to provide detailed information on a draft guidance on the content and format of the I...
FDA awards $5 million to the National Capital Consortium for Pediatric Device Innovation, led by Children's National Health System and University of M...
Federal Register notice: FDA renews the charter of its Dermatologic and Ophthalmic Drugs Advisory Committee for an additional two years.
FDA clears a Transseptal Solutions 510(k) for the TSP Crosser Transseptal Access System, a transseptal puncture system with a built-in steering mechan...
Federal Register notice: FDA renews for two years the charter of its Antimicrobial Drugs Advisory Committee.
Two Hyman, Phelps attorneys say there are times when a formal dispute resolution request can lead to an alternative path forward that helps the compan...
CDER launches a task force to assess and improve the Center workplace culture in terms of harassment, bullying, and civility.
Hogan Lovells attorneys review the changes in a new FDA draft guidance on the Special 510(k) Program.