Two medical device stakeholders suggest ways for FDA to regulate generative AI and foundation model-enabled medical devices.
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...
The union representing FDA employees sues President Trump over efforts to replace many Civil Service workers with political appointees.
The Trump Administration places a temporary embargo on external communications by FDA and other government health agencies until political appointees ...
FDA removes clinical hold on a Sanofi actual use trial to support its planned Rx-to-OTC switch for Cialis (tadalafil), which it licensed from Eli Lill...
Patient advocacy group Friends of Cancer Research adds former principal deputy commissioner Janet Woodcock to their board of directors.
