BsUFA III: Fiscal Years 2023-2027
New legislation will be required for FDA to continue collecting biosimilar user fees in future fiscal years. Information related to…
Ashfiat Alharamain Energy Support may be harmful due to hidden drug ingredient
The Food and Drug Administration is advising consumers not to purchase or use Ashfiat Alharamain Energy Support, a product promoted…
Black Thai Honey may be harmful due to hidden drug ingredient
The Food and Drug Administration is advising consumers not to purchase or use Black Thai Honey, a product promoted and…
Accelerated Approval Program
To allow for earlier approval of drugs that treat serious conditions and fill an unmet medical need based on a…
FDA Awards First-Ever National Priority Vouchers to Nine Sponsors
The U.S. Food and Drug Administration today announced 9 voucher recipients under the new Commissioner’s National Priority Voucher (CNPV) pilot…
Conducting Clinical Trials With Decentralized Elements
This guidance provides recommendations for sponsors, investigators, and other interested parties regarding the implementation of decentralized elements in clinical trials.…
Drug Supply Chain Security Act (DSCSA)
The Drug Quality and Security Act (DQSA) of 2013 — Law outlines critical steps to build a system to identify…
Guidance Snapshot Pilot
Guidance Snapshots are a communication tool that provide highlights from the document using visuals and plain language. This pilot program…
Rezafungin Injection
Rezafungin Injection Recognized Interpretive Criteria
17th Annual Sentinel Initiative Public Workshop – 11/06/2025
The U.S. Food and Drug Administration, under a cooperative agreement with the Duke-Margolis Institute for Health Policy, is hosting the…