FDA Related News

Biologics

Neurogene Gene Therapy Patient Dies After Dosing

Neurogene says a patient dosed in an ongoing Phase 1/2 gene therapy clinical trial for Rett syndrome has died.

Human Drugs

Endo Recalls Clonazepam Due to Mislabeling

Endo recalls (Class 1) clonazepam orally disintegrating tablets due to a potential mislabeling of the product strength.

Human Drugs

FDA Research Links Montelukast to Mental Issues

FDA researchers find potential links between the widely prescribed asthma drug montelukast (Organons Singulair) and serious mental health issues, Reut...

Medical Devices

Counterfeit Batteries Leads to Infusion Pump Recall

ICU Medical recalls its Plum Infusion Systems after receiving reports of allegedly counterfeit batteries being used with the devices.

Federal Register

Guide on 510(k) Third-Party Reviews

Federal Register notice: FDA makes available a final guidance entitled 510(k) Third Party Review Program and Third-Party Emergency Use Authorization (...

Medical Devices

CDRH New Pilot on High-Risk Recalls

CDRH says a new device recall pilot program aims to improve communication timeliness about corrective actions being taken by companies on high-risk re...

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IC-Green Not Withdrawn Due to Safety/Efficacy

Federal Register notice: FDA determines that Renew Pharmaceuticals IC-Green (indocyanine green) was not withdrawn from sale for reasons of safety or e...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