Federal Register notice: FDA announces an 11/16 Antimicrobial Drugs Advisory Committee meeting that will review a Bayer NDA for ciprofloxacin inhalati...
Federal Register notice: FDA makes available a guidance entitled Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Mod...
FDA releases the FDA-483 containing six observations from an inspection at Indias Divis Laboratories.
FDA finalizes a guidance to help drug companies wanting to participate in a program to include emerging technology in specified regulatory submissions...
Federal Register notice: FDA requests that any industry organizations interested in participating in the selection of nonvoting industry representativ...
FDA alerts vascular surgeons about Type IIIa and IIIb endoleaks with the use of endovascular graft systems for aneurysm repair procedures that treat a...
FDA approves an Eli Lilly NDA for Verzenio (abemaciclib) for treating adult patients who have hormone receptor-positive, human epidermal growth factor...
FDA clears an Expanding Orthopedics 510(k) for the FLXfit 15 3D Expandable Cage System for restoring lumbar lordosis while controlling sagittal and co...