Federal Register notice: FDA seeks industry organizations interested in participating in selecting a nonvoting industry representative to serve on CDR...
Federal Register notice: FDA announces a 5/22 Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee meeting to discuss requirement...
Some 31 experts in genetics, addiction, psychiatry, and medical devices call on FDA to revoke its approval of the AvertD DNA test that claims to predi...
In a delayed report to Congress, CDRH says it issued 45 medical device safety communications of various types in 2022.
FDA says the Medos International Srl recall of the Cerenovus Cerebase DA guide sheath is Class 1.
Liquidia says it believes there no longer are legal bars on FDA approving its Yutrepia inhalation powder for two indications.
Novartis says it will seek FDA approval for an expanded use for Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for slowing disease progression in pa...
Hogan Lovells attorneys say FDA may create new Centers of Excellence as it works to regulate AI in medical product development through cross-Center co...
