The New York Times reports that ongoing turmoil at FDA has increasingly placed commissioner Marty Makary under the microscope, raising concerns among ...
FDA faces Increased scrutiny of its newly established Commissioners National Priority Review voucher program, which is intended to accelerate the revi...
FDA Webview closes its newsroom for the end-of-year Holiday Season, reopening Monday, Jan 5, 2026.
FDA posts an updated guidance outlining its processes for bioresearch monitoring inspections, which oversee the conduct, reporting, and postmarketing ...
FDA cites a GlaxoSmithKline biologicals manufacturing site in Hungary for significant lapses in deviation investigations and material controls, includ...
A new FDA safety update says safety risks associated with AstraZenecas Andexxa outweigh the drugs benefits, leading the agency to ask the company to p...
FDA posts two separate Form 483 inspection reports citing a range of quality and compliance deficiencies at Catalent Maryland, Inc., highlighting ongo...
FDA seeks input on a new way to contract directly with venture capitalbacked innovators in an effort to possibly speed adoption of emerging technologi...
