FDA Related News

Human Drugs

Few ODAC Advisory Committee Questions Difficult: Study

University researchers say they found relatively few instances in which Oncology Drugs Advisory Committee members reported difficulty in voting on a q...

Human Drugs

FDA SSDC White Paper Out

CDER issues a white paper tracing the history of selective safety data collection (SSDC) and plans for the future.

Biologics

FDA Extends Review of GSK Multiple Myeloma BLA

FDA extends by three months its review of a GSK BLA for Blenrep (belantamab mafodotin) combinations for treating patients with relapsed or refractory ...

Human Drugs

Longer Drug Review Time Means Fewer Approvals: CBO

Responding to congressional Democrats, the Congressional Budget Office says a nine-month increase in FDA drug review times would lead to fewer drugs b...

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 ...