FDA Related News

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

Positive Trial Data on Sleep Apnea Drug

Apnimed announces positive topline results from its second pivotal Phase 3 trial of AD109 (aroxybutynin and atomoxetine), a once-daily oral pill for t...

FDAs Elsa Hallucinates Confidently: Report

Gizmodo reports that FDA employees who have used Elsa told CNN the AI tool makes up reports and hallucinates confidently.

Medical Devices

Baxter Recalls Mobile Lift Component

Baxter Healthcare recalls (Class 1) a mobile lift component used in several patient lift devices due to the risk of improper attachment.

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.