FDA Related News

Federal Register

Comments Sought on Pre-Hatch-Waxman ANDAs

Federal Register notice: FDA solicits comments on several issues related to FDAs post-approval regulation of certain drug products approved in abbrevi...

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...

Human Drugs

Researchers Get Jail Time for Falsifying Clinical Trial Data

A Florida federal judge sentences two people to jail time and restitution for participating in a conspiracy to falsify clinical trial data.

Medical Devices

CDRH Met or Exceeded Strategic Goals: Report

CDRH says it met or exceeded strategic goals in the period 2018-2020.

Human Drugs

FDA Approves Keytruda Plus Lenvima for Some Cancers

FDA approves Mercks Keytruda plus Eisais Lenvima for first-line treatment of adults with advanced renal cell cancer.

Human Drugs

FDA Orphan Drug Designation for Allogene Cancer Drug

FDA grants Allogenes ALLO-715 orphan drug status for treating multiple myeloma.

Human Drugs

Jazz Pharma Hypersomnia Drug Approved

FDA approves a Jazz Pharmaceuticals NDA for Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for treating idiopathic hypersomn...