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...
Federal Register notice: FDA announces a 9/10 joint meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic...
Smiths Medical recalls specific software versions used with its Medfusion 3500 and 4000 Syringe Pumps because of an error that may lead to fluid/medic...