Minneapolis Heart Institute researchers fault FDA and the medical device industry for not better managing and communicating about medical device produ...
CDER Emerging Technology Team director Sau Lee explains how the program aids industry to innovate and more easily meet regulatory requirements.
Harvard Medical School researchers say policymakers should be looking at high-cost drugs to determine why there arent more generic or biosimilar versi...
FDA approves an Astellas Pharma supplemental NDA for Mycamine (micafungin for injection) for treating candidemia and acute disseminated candidiasis, a...
Auburn University researchers say there is a significant increase in the average number of generic drug approval days for drugs for which one or more ...
Several stakeholders comment on an FDA reorganization plan for the Office of New Drugs intended to speed and facilitate drug development.
FDA asks for medical device industry cooperation with onsite verification of facility information provided to the agency.
Federal Register notice: FDA makes available a final guidance entitled Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Othe...