The Sedgwick third-quarter recall index sees a sharp increase in the number of affected drug and medical device units.
CBER director Vinay Prasad addresses a 12/4 investor conference in New York and defends his leadership, and attributing criticism to "misleading media...
CDER Office of Compliance director Jill Furman highlights a year of sweeping operational shifts, heightened enforcement, and emerging use of artificia...
FDA commissioner Marty Makary alleges that the Biden administration failed to disclose internal data on myocarditis risks in young people following Co...
Former FDA associate commissioner Peter Pitts says CDER director Richard Pazdurs decision to abruptly retire was motivated by growing political interf...
Capricor Therapeutics says Deramiocel, a cell therapy candidate targeting cardiomyopathy associated with Duchenne muscular dystrophy, achieved statist...
The CDER Accelerating Rare Disease Cures program Year-Three report shows a decline in new drug approvals and several other activities when compared wi...
The American Hospital Association suggests ways for FDA to develop a regulatory framework for measuring and evaluating AI-enabled medical devices.
