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FDA posts two separate Form 483 inspection reports citing a range of quality and compliance deficiencies at Catalent Maryland, Inc...[ Price : $8.95]
A new FDA safety update says safety risks associated with AstraZenecas Andexxa outweigh the drugs benefits, leading the agency to ...[ Price : $8.95]
FDA seeks input on a new way to contract directly with venture capitalbacked innovators in an effort to possibly speed adoption of...[ Price : $8.95]
FDA posts an updated guidance outlining its processes for bioresearch monitoring inspections, which oversee the conduct, reporting...[ Price : $8.95]
FDA faces Increased scrutiny of its newly established Commissioners National Priority Review voucher program, which is intended to...[ Price : $8.95]
FDA cites SCA Pharmaceuticals for multiple deficiencies in sterile drug manufacturing practices following a 10-day inspection of t...[ Price : $8.95]
The CDER Office of Prescription Drug Promotion says a TV spot for Karuna Therapeutics Cobenfy is false or misleading in its descri...[ Price : $8.95]
FDA releases the form FDA-483 with five observations from a recent inspection of the UBI Pharma drug manufacturing facility in Hsi...