How to Report a Shortage or Supply Issue

Please see our new website:Drug Shortages Database Search For Industry: Send FDA Drug Shortage and Supply NotificationsIndustry can notify FDA Drug Shortage Staff via CDER Direct NextGen Portal. This portal is intended ONLY for drug manufacturers/applicants. Industry...

CBER 2025 Orphan Approvals (new BLAs)

This list reflects information regarding the applications as of the approval date. It is not updated with regard to applicant or application status changes. The applications are listed by date of approval in reverse chronological order.Trade Name/Proper...