FDA Related News

Human Drugs

FTC Should Look Into Par Vasostrict Petition: FDA

FDA denies a Par Sterile Products petition saying it failed to raise valid scientific or regulatory issues and was submitted as a delaying tactic.

Human Drugs

Guide on Inspecting Injectables for Particulates

FDA posts a draft guidance entitled Inspection of Injectable Products for Visible Particulates.

Medical Devices

Proposed Rule on QSR Harmonization Soon: Maisel

CDRH Office of Product Evaluation and Quality director William H. Maisel tells an industry conference that the agency is planning to release very soon...

Human Drugs

FDA Modifies REMS for Mifepristone

FDA modifies a Risk Evaluation and Mitigation Strategies program for mifepristone, a drug used in early abortion and miscarriage care.

Medical Devices

Getinge/Datascope/Maquet Cardiosave Recall is Class 1

FDA says the Getinge/Datascope/Maquet recall of Cardiosave intra-aortic balloon pumps is Class 1.

Drug, Device Violations in Dental Technologies Inspection

FDA warns Lincolnwood, IL-based Dental Technologies about CGMP and QS regulation violations at its contract drug and medical device manufacturing faci...

Biologics

FDA Revises Janssen Covid Vaccine Fact Sheets

FDA says fact sheets for the Janssen Covid-19 vaccine have been updated with a Contraindication for the vaccine in individuals with a history of throm...

Medical Devices

Device Definition Draft Guidance

FDA issues a draft guidance on the redesignation of the definition of device in the Federal Food, Drug, and Cosmetic Act and the addition of a definit...

Federal Register

Abdominal Pain Nerve Stimulator is Class 2

Federal Register notice: FDA classifies the nonimplanted nerve stimulator for functional abdominal pain relief into Class 2 (special controls).

Federal Register

Endoscopic Transhepatic Venous Needle is Class 2

Federal Register notice: FDA classifies the endoscopic transhepatic venous access needle into Class 2 (special controls).