FDA Related News

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.

Human Drugs

CGMP Violations at Indias Sun Pharmaceutical

FDA warns Sun Pharmaceuticals about CGMP violations and other issues in its production of finished drugs in Gujarat, India.

Federal Register

Model-Informed Drug Development Meetings Continue

Federal Register notice: FDA announces the continuation of its Model-Informed Drug Development Paired Meeting Program as part of the recent user fee r...

Federal Register

Correction Notice on Advisory Committee Charter Renewal

Federal Register notice: FDA corrects a 12/13/2022 notice entitled Advisory Committee; Cardiovascular and Renal Drugs Advisory Committee; Renewal.

Human Drugs

Standardizing REMS Information in SPL

CDER Office Medication Error Prevention and Risk Management director Claudia Manzo describes the change in REMS format to SPL.

Human Drugs

Valisure FDA-483 on Lab Practices Released

FDA posts a six-item Form FDA-483 that cites analytical laboratory Valisure over deficient laboratory practices after a 5/26-7/6/22 agency inspection....