FDA Related News

Remote Regulatory Assessment Q&A Guidance

FDA publishes a guidance with questions and answers on its various remote regulatory assessment tools.

Medical Devices

Device Cybersecurity Quality System Consideration Guide

FDA posts a final guidance entitled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.

Human Drugs

FDA RMAT Designation for Detalimogene

FDA grants regenerative medicine advanced therapy designation for enGene Holdings bladder cancer drug detalimogene.

Human Drugs

Viatris Plans NDA for MR-141 in Presbyopia

Viatris plans to submit an NDA later this year for phentolamine ophthalmic solution 0.75% for treating presbyopia based on just-released data from a P...

Human Drugs

Syndax Gets Priority Review for Revuforj sNDA

FDA grants Syndax Pharmaceuticals a priority review of its supplemental NDA for Revuforj (revumenib) as a treatment for relapsed or refractory acute m...

FDA General

Reverse FDA Restructuring: Former GOP Representative

Former GOP Rep. John Doolittle calls for immediate steps to reverse some of the FDA restructuring that he says will hurt regulated companies, patients...

Medical Devices

InspireMD PMA Approved for Carotid Stent

FDA approves an InspireMD PMA for its CGuard Prime Carotid Stent System for treating carotid artery stenosis.

Medical Devices

Cook Medical Recalls Beacon Angiographic Catheter

Cook Medical recalls its Beacon Tip 5.0 Fr Angiographic Catheter because it may experience tip separation.

Human Drugs

Sterling Drug Supply Chain Violations

FDA warns Sterling Distributors about its multiple violations of the Drug Supply Chain Security Act.

Human Drugs

Guide on Developing Drugs for Lyme Disease

FDA posts a final guidance entitled Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment.