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 […]

In September 2022, the FDA User Fee Reauthorization Act of 2022 (FDAUFRA) was enacted, which included the third reauthorization of the Generic Drug User Fee Amendments […]

On October 8, 2025, the Food and Drug Administration approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals Inc.) for the adjuvant treatment of adults with cutaneous squamous cell carcinoma […]

Safety Pharmacology General safety pharmacology testing Safety pharmacology endpoints may be incorporated into general toxicity studies in order to reduce animal use. This practice is routine […]

Action Today, the U.S. Food and Drug Administration (FDA) approved Jascayd (nerandomilast) tablets to treat idiopathic pulmonary fibrosis (IPF), a rare, serious, and progressive disease with […]