FDA Related News

Federal Register

IC-Green Not Withdrawn Due to Safety/Efficacy

Federal Register notice: FDA determines that Renew Pharmaceuticals IC-Green (indocyanine green) was not withdrawn from sale for reasons of safety or e...

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

PCCP Draft Guidance Stakeholder Recommendations

Two stakeholders request changes to an FDA draft guidance on predetermined change control plans for medical devices.

Federal Register

FDA Revokes EUAs on Covid Tests

Federal Register notice: FDA revokes the Emergency Use Authorizations issued to Cue Health for the Cue Covid19 Test, and Cue Covid19 Home/OTC Test.

Federal Register

FDA Provides More Draft ANDA-Specific Guidances

Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances for generic drug sponsors.

Human Drugs

Fludarabine Phosphate Labeling Changes OKd

FDA announces approved labeling changes for Sandoz fludarabine phosphate injection under the Oncology Center of Excellences Project Renewal.