FDA clears an Ambu 510(k) for its Ambu aScope Gastro and Ambu aBox 2 display, the companys first sterile single-use gastroscope, which includes new ad...
Federal Register notice: FDA announces a 2/15 vaccines advisory committee meeting to discuss a request to amend the Emergency Use Authorization of Pfi...
Federal Register notice: FDA classifies the alternate controller enabled infusion pump into medical device Class 2 (special controls).
FDA posts a draft guidance on antibody-drug conjugate clinical pharmacology considerations.
Writing in the 2/4 The Lancet, FDA Oncology Center of Excellence director Richard Pazdur calls into question the development of dozens of oncology dru...
A just-released Government Accountability Office report offers recommendations on an FDA-planned pilot program to test unannounced foreign inspections...
Federal Register notice: FDA extends the comment period for a 1/11 notice about a draft guidance entitled Notifying the Food and Drug Administration o...
Federal Register notice: FDA posts a draft guidance on over-the-counter monograph drug formal meetings between the agency and sponsors.