HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]

Docket Number: FDA-2021-D-1051 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance provides recommendations to assist […]

Summary Company Announcement Date: March 28, 2024 FDA Publish Date: March 28, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Device & Drug Safety […]

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 […]