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 […]

[10-06-2025] The Food and Drug Administration is advising consumers not to purchase or use Mojo Max Fusion XXX, a product promoted and sold for sexual enhancement […]

[10-6-2025] The Food and Drug Administration is advising consumers not to purchase or use Osteo Sin Max, a product promoted and sold for joint pain on […]

[10-3-2025] The Food and Drug Administration is advising consumers not to purchase or use Contra Reumas, a product promoted and sold for joint pain on various websites, […]

Overview The Integrated Assessment of Marketing Applications, developed as part of the New Drugs Regulatory Program (NDRP) Modernization, includes an updated process and review template for […]

[10/3/2025] Today, the U.S. Food and Drug Administration (FDA) is announcing a new pilot prioritization program for the review of abbreviated new drug applications (ANDAs) that aims […]