FDA releases the FDA-483 with five observations from an inspection at the Lupin facility in Andhra, Pradesh, India.
FDA warns consumers and healthcare professionals about the significant safety risks associated with using dietary supplements containing cesium salts.
FDA warns Marco Pharma about CGMP and misbranding violations in its production of dietary supplements.
Former Washington Legal Foundation chief counsel Richard Samp says the FDA launch of its CURE ID program to collect information on off-label prescribi...
Former FDA commissioner Scott Gottlieb expects the U.S. to see the coronavirus further spreading across the nation, and globally he expects it to get ...
FDA clears a BioElectronics 510(k) for its over-the counter ActiPatch medical device and an expanded indication adjunctive treatment of musculoskelet...
FDA grants EyeYon Medical a breakthrough device designation for its EndoArt Artificial Endothelial Layer Implant.
Romark Laboratories asks FDA to require several bioequivalence tests for any ANDA citing Romarks Alinia as the reference-listed product.