FDA issues a device correction alert after Olympus recalled (Class 1) the instructions for its Single Use Ligating Device PolyLoop, warning that impro...
provals managing director Steven Cohen lists the many benefits of FDA advisory committees even as the agency has reduced its use of them significantly...
The CDER Office of Prescription Drug Promotion says a Daiichi Sankyo promotional video patient testimonial for its Turalio misleadingly creates the im...
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.
A new Bloomberg report finds that two Republican lawmakers were barred from attending a 12/3 FDA meeting concerning the potential expanded approval of...
