[10-17-2025] The Food and Drug Administration is advising consumers not to purchase or use Ashfiat Alharamain Energy Support, a product promoted and sold for male sexual […]

[10-17-2025] The Food and Drug Administration is advising consumers not to purchase or use Black Thai Honey, a product promoted and sold for male sexual enhancement […]

For Immediate Release: October 16, 2025 The U.S. Food and Drug Administration today announced nine voucher recipients under the new Commissioner’s National Priority Voucher (CNPV) pilot […]

Docket Number: FDA-2022-D-2870 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Center for Devices and Radiological Health […]

Exceptions or additions to the recognized standards   Minimum Inhibitory Concentrations(mcg/mL) Disk Diffusion(zone diameters in mm) Pathogen S I R S I R Candida albicans ≤0.12 […]

On This Page Date: November 6, 2025 Time: 9:00 a.m. – 3:00 p.m. ET Location: Event Location FDA HeadquartersFDA White Oak Campus 10903 New Hampshire Ave, […]

On December 13, 2016, the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD pathway) was added to the Federal Food, Drug, and Cosmetic (FD&C) Act […]

Delivery Method: Certified Mail Reference #: 320-25-97 Product: Drugs Over-the-Counter Drugs Recipient: Recipient Name Dr. Sayed Ibrahim Recipient Title President and Chief Executive Officer Health and […]

Generic drug user fees make it possible for FDA and industry to continue to ensure that the American public has access to safe, effective and high-quality […]