FDA Related News

Medical Devices

2 Olympus Endoscope Warning Letters

FDA warns two Olympus endoscope and reprocessor manufacturing facilities about Quality System and Medical Device Reporting regulation violations.

Human Drugs

PhRMA Expresses ICH Q12 Guidance Concerns

Pharmaceutical Research and Manufacturers of America raises some issues with the International Conference on Harmonization Q12 guidance published by F...

Medical Devices

Guide on 510(k) Submissions for Photobiomodulation Devices

FDA posts a draft guidance entitled Photobiomodulation (PBM) Devices Premarket Notification 510(k) Submissions.

Human Drugs

AstraZeneca Asthma Drug Approved by FDA

FDA approves an AstraZeneca NDA for Airsupra (albuterol/budesonide) for the as-needed treatment or prevention of bronchoconstriction and to reduce the...

Federal Register

EUA Granted for Monkeypox Diagnsotic

Federal Register notice: FDA issues an emergency use authorization for a Life Technologies in vitro diagnostic device for detecting and diagnosing mon...

Biologics

Vaccine Advisors Angry at Lack of Transparency

Some FDA and CDC vaccine advisors say they should have been given Moderna Covid booster infection data, even though it was early and had limitations, ...

FDA General

We Agree: FDA Should Jettison Foods

FDA Webview editor Jim Dickinson supports a Washington Post editorial board recommendation made after a meeting with the agencys leadership that food ...

Medical Devices

Criminal Probe Nets 2 Guilty Pleas Over Stolen Test Strips

An FDA Office of Criminal Investigations probe leads to guilty pleas by Jennifer Robertson (Battle Creek, MI) and Michelle McAllister (Jerome, MI) ove...

Medical Devices

Many Recalled 510(k) Devices Had Recalled Predicates: Study

Academic medical center researchers say a loophole in the law allows FDA to clear 510(k) submissions whose predicate was subject to a Class 1 recall.

Attorneys Look Back, Ahead at FDA

SheppardMullin attorneys review FDA 2022 actions in several regulatory areas and look ahead to 2023.