FDA says it will temporarily allow the distribution of some rifampin and rifapentine with nitrosamine impurities to avoid shortages while manufacturer...
FDA commissioner Stephen Hahns controversial remarks exaggerating the efficacy of convalescent plasma touches off a wider examination of those advisin...
FDA says it is removing a Boxed Warning about amputation risk on Janssens diabetes drug canagliflozins (Invokana, Invokamet, Invokamet XR) prescribing...
CBER updates its Calendar Year 2020 guidance agenda listing 28 planned guidances in four categories.
CDER publishes a MAPP describing responsibility in the Office of Generic Drugs for processing drug application ownership changes in the Orange Book.
FDA warns Custom Nutraceuticals about CGMP violations that adulterate its dietary supplements.
FDA approves Recordatis Cystadrops for reducing cystine crystal deposits in the cornea of the eye.
The Justice Department says Dusa will pay $20.75 million to resolve a whistleblowers charges that it induced doctors to file false claims for its Levu...