FDA is aware of news reports of devastating, ongoing diethylene glycol (DEG) and ethylene glycol (EG) contamination in children’s cough and cold medicine in India. FDA […]

Docket Number: FDA-2025-D-3217 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This draft guidance provides guidance to […]

For Immediate Release: May 22, 2023 Español Today, the U.S. Food and Drug Administration approved Opvee, the first nalmefene hydrochloride nasal spray for the emergency treatment […]

For Immediate Release: March 29, 2023 Español Today, the U.S. Food and Drug Administration approved Narcan, 4 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), […]

Summary Company Announcement Date: September 20, 2024 FDA Publish Date: September 23, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to Presence of […]

Date: November 19 – 20, 2025 Time: 8:30 a.m. – 5:00 p.m. ET Location: Event Location The Universities at Shady GroveBuilding II 9630 Gudelsky DriveRockville, MD […]

Date: January 21, 2026 Time: 1:00 p.m. – 2:30 p.m. ET Join the Event on January 21, 2026 No Registration is Required for this Free Virtual […]

For Immediate Release: July 14, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  On Thursday, […]

For Immediate Release: January 19, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]