FDA Related News

Human Drugs

Objectionable Conditions at Hospital IRB

FDA warns the Kittanning, PA-based Armstrong County Memorial Hospital IRB about objectionable conditions identified in a Bioresearch Monitoring Progra...

FDA Cant Regulate AI on its Own: Califf

FDA commissioner Robert Califf says collaboration with external stakeholders is needed to adequately monitor and regulate artificial intelligence.

Human Drugs

Acadia Unloads Priority Voucher for $150 Million

Acadia Pharmaceuticals sells its Rare Pediatric Disease Priority Review Voucher for $150 million.

Medical Devices

FDA OKs Envoy Medical Cochlear Implant Study

FDA approves an Envoy Medical IDE for its pivotal study of the Acclaim Fully Implanted Cochlear Implant.

Human Drugs

Extended Review for Organons Vtama sNDA

FDA extends by three months its review of an Organon supplemental NDA for Vtama (tapinarof) cream and its use for treating atopic dermatitis.

Human Drugs

CGMP Issues at Chinas Shandong Boyuan

FDA issues an untitled letter to Chinas Shandong Boyuan Pharmaceutical Co. about CGMP deviations in its manufacturing of active pharmaceutical ingredi...

Human Drugs

Analytical Food Laboratories CGMP Violations

FDA warns Grand Prairie, TX-based Analytical Food Laboratories about CGMP violations in its work as a drug contract testing laboratory.

Medical Devices

FDA Clears SimBioSys TumorSight Expanded Use

FDA clears a SimBioSys 510(k) for TumorSight Viz to expand its use by breast surgeons through artificial intelligence-based image processing.

Biologics

Merus Zeno BLA Gets 3 Month Review Extension

FDA extends by three months its priority review of a Merus BLA for Zeno (zenocutuzumab) for treating patients with certain types of lung and pancreati...

Support, Suggestions for FDA Rare Disease Hub

Four rare disease stakeholders say they support an FDA plan to create a Rare Disease Innovation Hub and suggest its initial priorities.