FDA Related News

Medical Devices

SD Biosensor Recalls Contaminated Covid Tests

SD Biosensor recalls its Pilot Covid-19 At-Home Test due to microbial contamination.

Call Out Lawyer Client-Seeking Ads: Petition

A University of Florida law professor calls on FDA to define personal injury attorney client-seeking ads that cross a line and may harm patients using...

Human Drugs

FDA Denies Petition for PPI Pneumonia Warning

FDA denies an Alliance for Natural Health citizen petition urging the agency to require all makers of proton pump inhibitors to expand the existing la...

Human Drugs

Contract Testing Lab Gets Warning Letter

FDA sends contract testing laboratory Sure-Biochem Laboratories a Warning Letter after a 10/2022 inspection cited significant GMP violations associate...

FDA General

New FDA MOU for Distributed Manufacturing

FDA and the Veterans Health Administration announce a new memorandum of understanding to advance distributed manufacturing and digital stockpiles for ...

Human Drugs

Figures in Tellus Clinical Trial Fraud Case Acquitted

A Miami federal jury 5/18 acquits Tellus Clinical Research CEO Fidalgis Font and clinical study coordinator Julio Lopez in their alleged role of falsi...

Human Drugs

Safety Alert on Pediatric Cough Drops

FDA issues a safety alert on Novis-branded over-the-counter G-Supress DX Pediatric Drops because they may contain the incorrect product and cause pati...

Federal Register

Regulatory Review Period Corrected for Enspryng

Federal Register notice: FDA corrects a 7/13/2022 notice that announced the regulatory review period determination for Genentechs Enspryng (satralizum...

Human Drugs

Ex-FDAer Schiller on Accelerated Approval Guide

Aetion chief legal/regulatory officer and former FDA associate commissioner for policy Lowell Schiller says the agency should address the use of exter...