US FDA

CGMP/Finished Pharmaceuticals/Adulterated

CDER Data Standards Program

The Data Standards Strategy reinforces CDER’s ongoing commitment to the development, implementation, and maintenance of a comprehensive data standards program that will facilitate the efficient and effective review of regulatory submissions. This helps bring safe and effective products to market.

Biosimilars Research: Awards

The U.S. Food and Drug Administration (FDA) is hosting a hybrid in-person/virtual meeting on September 18, 2025, to meet the BsUFA III Commitment to review the progress of the pilot program’s aims, or demonstration projects, and solicit input on future priorities.

FDA is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Generic Drug User Fee Amendments for fiscal years 2028 through 2032.

GDUFA Type II API DMF Payment Receipts Report

FDA provides consumers and industry with safety, regulatory and availability information for various drugs by drug class. From A to Z. Topics include: acetaminophen, estrogen, insulin, opioids, statins, and weight-loss drugs.

FDA Listing of Authorized Generics

Innovative drugs often mean new treatment options for patients and advances in health care for the American public.

The FDA is raising awareness about cybersecurity vulnerabilities with Contec CMS8000 and Epsimed MN-120 patient monitors.

The FDA is revising the labeling of all extended-release stimulants indicated to treat attention-deficit/hyperactivity disorder (ADHD) – including certain formulations of amphetamine and methylphenidate – to warn about the risk of weight loss and other adverse reactions (side effects) in patients yo