FDA posts an updated guidance outlining its processes for bioresearch monitoring inspections, which oversee the conduct, reporting, and postmarketing ...
FDA faces Increased scrutiny of its newly established Commissioners National Priority Review voucher program, which is intended to accelerate the revi...
The New York Times reports that ongoing turmoil at FDA has increasingly placed commissioner Marty Makary under the microscope, raising concerns among ...
FDA cites a GlaxoSmithKline biologicals manufacturing site in Hungary for significant lapses in deviation investigations and material controls, includ...
FDA posts two separate Form 483 inspection reports citing a range of quality and compliance deficiencies at Catalent Maryland, Inc., highlighting ongo...
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...
House and Senate Democratic health leaders ask AstraZeneca, Lilly, Novo Nordisk, and Pfizer for details about the drug pricing deals the companies mad...
FDA cites SCA Pharmaceuticals for multiple deficiencies in sterile drug manufacturing practices following a 10-day inspection of the companys facility...
