FDA Related News

Human Drugs

FDA Touts Use of Real-World Evidence in Prograf Approval

Three FDA officials say the recent approval of Astellas Prograf for a new indication demonstrates that real-world data observational studies can be co...

Human Drugs

FDA Complete Response Letter for Ardelyx Tenapanor NDA

An FDA complete response letter says an Ardelyx NDA for tenapanor did not show sufficient treatment effect to be approved.

Federal Register

Workshop on Pediatric Complex Trial Designs

Federal Register notice: FDA announces a public workshop entitled Advancing the Development of Pediatric Therapeutics Complex Innovative Trial Design...

Medical Devices

FDA Faulted for Lax Device Issue Follow-up

Pro Publica details the cases of several people harmed by Medtronics HeartWare ventricular assist device and says FDA relied too much on the company t...

Medical Devices

Pillar Biosciences PMA Approved for Diagnostic

FDA approves a Pillar Biosciences PMA for its oncoReveal Dx Lung and Colon Cancer Assay, a next-generation sequencing tissue-based companion diagnosti...

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...