FDA Related News

Human Drugs

FDA Accepts Keytruda sBLA, Sets Priority Review

FDA accepts a Merck sBLA for a new Keytruda melanoma indication and will conduct a priority review.

Medical Devices

Eight Medical Recirculator Lavage Kit Recall is Class 1: FDA

FDA says the Eight Medical recall of Recirculator 8.0 disposable lavage kits is Class 1.

Medical Devices

Eco-Med Pharma Recalls Ultrasound Gel

Eco-Med Pharmaceuticals recalls certain lots of its Eco-Gel 200 ultrasound gel due to bacterial contamination.

Human Drugs

OIG Report on Accelerated Approval Due in 2023

The HHS Office of Inspector General says it expects to report in 2023 on its review of the FDA accelerated approval pathway.

Specialty Doctors Losing Faith in FDA: Survey

A Spherix survey of specialty physicians finds a declining faith in FDA due to specialty-specific experiences with drug approvals and other FDA activi...

Human Drugs

FDA Cant Approve Treosulfan NDA in its Present Form: CRL

FDA says it cant approve a Medexus NDA for treosulfan in its present form.

Medical Devices

FDA Clears Camber Spine Spacers

FDA clears a Camber Spine 510(k) for both its Spira-P Posterior Lumbar Spacer technology and Spira-T Oblique Posterior Lumbar Spacer technologies.

Human Drugs

Rare Disease Firms Urge Accelerated Approval Support

The Rare Disease Company Coalition calls on House and Senate leaders to strengthen the FDA accelerated approval pathway and block payment and coverage...

Medical Devices

BD to Start Alaris Software Remediation

BD says it will start remediation of a 2020 recall of its Alaris infusion pump system with a new software version.

Federal Register

Covid EUA Listing Updated

Federal Register notice: FDA updates its listing of Emergency Use Authorizations (EUAs) for use during the COVID-19 pandemic to reflect recent EUAs gr...