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Last updated 1 day ago
Addressing the Public Health Effects of Opioid Medications - 09/09/2026
1 day ago
On September 9, 2026, the U.S. Food and Drug Administration, in partnership...
FDA Actions to Accelerate and Modernize Early and Late-Stage Clinical Development
3 days ago
Learn more about actions to accelerate and modernize clinical research across the...
Phase 1 Investigational New Drug (IND) Navigator
3 days ago
The Phase 1 IND Navigator provides the tools, guidances, and regulatory expertise...
Commissioner's National Priority Voucher (CNPV) Pilot Program
3 days ago
FDA Commissioner's National Priority Voucher Program. The Commissioner's National Priority Voucher Program...
FDA/Center for Research on Complex Generics (CRCG) Workshop on Advancing Bioequivalence Frameworks for Inhalation Drug Products: Optimizing In Vitro, In Vivo, and In Silico Methods - 10/14/2026
2 days ago
Advancing Bioequivalence Frameworks for Inhalation Drug Products: Optimizing In Vitro, In Vivo...
FDA grants accelerated approval to iberdomide with daratumumab and hyaluronidase-fihj and dexamethasone for multiple myeloma
3 days ago
On August 13, 2026, the Food and Drug Administration granted accelerated approval...
Completed BsUFA III Deliverables
3 days ago
Since the passage of the Biosimilar User Fee Act (BsUFA) in 2012...
Information Regarding Insulin Storage and Switching Between Products in an Emergency
3 days ago
Updated
Laboratory Information Bulletins
3 days ago
Laboratory Information Bulletins available to the public
PDUFA VIII: Fiscal Years 2028 – 2032
3 days ago
Information related to FDA’s preparation for the seventh reauthorization of PDUFA.