FDA Related News

Human Drugs

MXBBB Recalls Umary Hyaluronic Acid Tablets

FDA says MXBBB has recalled one lot of Umary hyaluronic acid caplets that contain undisclosed diclofenac and omeprazole.

Over 290 OCI Arrests in FY 2023: FDA

FDA assistant commissioner Justin Green reports on over 290 arrests last year by the agencys Office of Criminal Investigations.

Medical Devices

Burdensome Device Assessment Guidance: Post

Two medical device experts use a Hyman, Phelps & McNamara post to urge FDA to provide additional guidance to ease what they see as burdensome recommen...

FDA General

Johns Hopkins Surgeon Eyed for FDA Top Job

News outlets report that Johns Hopkins surgeon Marty Makary is likely to be nominated by president-elect Donald Trump as the next FDA commissioner.

Medical Devices

Need for Device Transparency Seen in Celect Case

Academic medical center authors writing in the Annals of Internal Medicine say litigation involving the Cook Celect IVC filter demonstrates the need f...

Medical Devices

Draeger Atlan Recall is Class 1

FDA says the Draeger recall correction of its Atlan A350 and A350XL anesthesia workstations is Class 1.

Medical Devices

Smiths Recalls Infusion Pump Battery Packs

Smiths Medical recalls (Class 1) its CADD-Solis Li-ion Rechargeable Battery Packs to update instructions for use due to a potential battery malfunctio...

Federal Register

Fortesta Not Withdrawn Due to Safety/Efficacy

Federal Register notice: FDA determines that Endos Fortesta (testosterone) gel was not withdrawn due to safety or effectiveness reasons.

Medical Devices

Third-Party Review Guidance

FDA publishes a guidance with information on third-party review of 510(k)s and emergency use authorizations.

Marketing

New DTC Major Statement Standards Become Effective

New FDA advertising standards require drug marketers to ensure their direct-to-consumer advertisements major statement is presented in a clear, conspi...