Summary Company Announcement Date: March 27, 2024 FDA Publish Date: March 27, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Super potent due to […]

On This Page Date: May 9, 2024 Time: 1:00 PM – 3:30 PM ET AGENDA Coming Soon Visit CDER Small Business and Industry Assistance Page ABOUT […]

On This Page Date: May 16, 2024 Time: 1:00 PM – 2:30 PM ET Visit CDER Small Business and Industry Assistance Page ABOUT THIS WEBINAR This […]

This proposed rule, if finalized, would reestablish the ban of electrical stimulation devices (ESDs) for self-injurious or aggressive behavior, following the Agency’s now clarified authority to […]

Discussions with key Center for Drug Evaluation and Research (CDER) leadership about important regulatory and policy issues Content current as of: 03/26/2024 Regulated Product(s)

12/6/2023 Final Guidance Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs Notice of Availability 11/20/2023 Notice Implementing Interoperable Systems and Processes […]

For Immediate Release: March 26, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  On Monday, […]

For Immediate Release: March 26, 2024 The U.S. Food and Drug Administration is warning consumers not to use certain over-the-counter analgesic (pain relief) products that are […]

Product: CosmeticsDrugs Issuing Office: Center for Drug Evaluation and Research | CDER United States Secondary Issuing Offices United States WARNING LETTER March 25, 2024 RE: 3015204327 […]