The Office of Generic Drugs science and research report for FY 2018 says 13 research contracts and 11 grants for innovative research were funded.
Federal Register notice: FDA submits to OMB an information collection extension for Center for Devices and Radiological Health Appeals Processes.
Novartis says it has reserved about $700 million to settle U.S. government allegations that it illegally enticed physicians to prescribe its drugs.
FDA accepts for review a Horizon Therapeutics NDA for a new dosage form for Procysbi (cysteamine bitartrate) delayed-release oral granules in packets...
An Arkansas federal court orders J and L Grocery (Alma, AR) to stop distributing drug products, medical devices, cosmetics and food until the company ...
A Milwaukee Journal Sentinel investigative report says 62% of biologics approved by FDA carry a Boxed Warning, much higher than the percentage for new...
Federal Register notice: FDA seeks an information collection extension on its guidance on emergency use authorizations.
Amarin says it will respond to a citizen petition asking for a synthetic omega-3 exclusion from dietary supplement structural requirements by demonstr...