Two medical device stakeholders suggest ways for FDA to regulate generative AI and foundation model-enabled medical devices.
FDA will review a Biogen sNDA for a Spinraza higher dose regimen.
FDA removes information and documents regarding several diversity-related initiatives and policies, presumably in response to a Trump Administration E...
Former FDA associate commissioner for womens health Susan Wood passes away at her home in London after battling glioblastoma (brain cancer).
A bipartisan group of senators reintroduce legislation to mandate the inclusion of drug prices in direct-to-consumer ads.
FDA says it is adding a Boxed Warning for anaphylaxis to the labeling for Tevas multiple sclerosis drug Copaxone and its Sandoz generic.
CBER director Peter Marks report for 2024 discusses Center approval of 67 products it says integrated advances in science and technology.
The U.S. Court of Federal Claims grants FDA summary judgment on the pleadings and rejects Vandas 5th Amendment taking argument about FDA disclosure of...
