FDA Related News

Medical Devices

Baxter Recalls Infusion Pump Dosing Software

Baxter Healthcare recalls its Dose IQ Safety Software used with the Spectrum IQ Infusion System due to a software defect.

Human Drugs

Breakthrough Granted to Nasopharyngeal Carcinoma Drug

FDA grants a breakthrough therapy designation to Shanghai Junshi Biosciences and Coherus BioSciences for toripalimab in combination with chemotherapy ...

FDA or Courts Should Rethink Off-Label Rules: Cato

The Cato Institute says if FDA wont resolve its conflicting stance over off-label use and promotion, the courts should do so.

Human Drugs

Vifor Asks FDA to Reverse Some Venofer Actions

Vifor asks FDA to take specific steps to stay actions the agency took in a 2020 citizen petition response purporting to change the established names a...

Federal Register

FDA Seeks Consumer Reps for Advisory Panels

Federal Register notice: FDA seeks consumer organizations interested in participating in the selection of voting and nonvoting consumer representative...

Human Drugs

Appeals Court Says Teva Carvedilol Sale Induced Patent Infringement

The Federal Circuit Court of Appeals says promotional materials developed by Teva were enough to induce infringement of a GSK carvedilol patent despit...

Medical Devices

Captains Cloth Selling Unapproved KN95 Masks: FDA

FDA warns Captains Cloth it is marketing unapproved, adulterated, and misbranded KN95 face masks.

Federal Register

Patient Engagement Panel on Device Recalls

Federal Register notice: FDA announces a 10/6 Patient Engagement Advisory Committee meeting that will discuss and make recommendations on medical devi...

Human Drugs

FDA Wants More Study of FibroGen Roxadustat

An FDA complete response letter asks FibroGen to conduct additional roxadustat clinical studies before resubmitting its NDA.

Medical Devices

FDA Says Vivera Selling Adulterated, Misbranded Covid Tests

FDA warns Vivera Pharmaceuticals it is marketing unapproved, adulterated, and misbranded Covid-19 tests.