FDA Related News

Medical Devices

FDA Alert on Baxters Infusion Pump

FDA issues an early alert highlighting serious safety concerns with Baxter's Novum IQ large volume infusion pump.

Human Drugs

Official Action Indicated Rare in GCP Inspections: Report

FDA researchers analyze the results of good clinical practice inspections from 2017 to 2023, finding that less than 1% resulted in an official action ...

FDA: Multiple Violations at O3UV

FDA warns Grand Ledge, MI-based O3UV about multiple CGMP violations in its illegal production of autohemotherapy devices.

Human Drugs

CGMP Violations at Glenmark Unit

FDA warns Indias Glenmark Pharmaceuticals about CGMP violations in the production of finished drugs at one of its manufacturing facilities.

Biologics

FDA Rejects Replimune BLA for Melanoma Therapy

FDA rejects a Replimune priority-reviewed BLA for its melanoma therapy RP1 (vusolimogene oderparepvec).

Biologics

FDA Wins as Sarepta Folds and Stops Shipping Elevidys

FDA wins the latest round in its regulatory battle against gene therapy maker Sarepta Therapeutics after the company agrees to stop shipping Duchenne ...

Human Drugs

Lax GLP-1 Compounding Regulation Hurts Patients: Report

Center for Medicine in the Public Interest president Peter Pitts says FDA must protect patients by tightening its regulation of compounding pharmacies...

Biologics

Laura Loomer Urges Ouster of CBER Head Prasad

Conspiracy theorist and Trump confidant Laura Loomer urges the firing of CBER director Vinay Prasad due to his previous anti-Trump rhetoric and lifelo...

Medical Devices

Maquet Servo Ventilators in Class 1 Recall

Maquet Critical Care recalls (Class 1) its Servo Ventilator Systems to update their use instructions due to the risk of inaccurate compliance measurem...

Human Drugs

Industry Vet and Academic Tidmarsh Named CDER Head

FDA names Stanford pediatrics adjunct professor George Tidmarsh, an industry veteran for over 30 years, as the new CDER director.