FDA names physicianepidemiologist Tracy Beth Heg as CDER acting director, replacing director Richard Pazdur, who submitted his retirement paperwork ea...
Former FDA associate commissioner Peter Pitts says CDER director Richard Pazdurs decision to abruptly retire was motivated by growing political interf...
A new Bloomberg report finds that two Republican lawmakers were barred from attending a 12/3 FDA meeting concerning the potential expanded approval of...
A dozen former FDA commissioners warn that sweeping internal directives proposed by CBER director Vinay Prasad would undermine evidence-based vaccine ...
The CDER Office of Prescription Drug Promotion says a Daiichi Sankyo promotional video patient testimonial for its Turalio misleadingly creates the im...
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 American Hospital Association suggests ways for FDA to develop a regulatory framework for measuring and evaluating AI-enabled medical devices.
