An FDA review found the side effects on mood, behavior, or thinking with the stop-smoking medicines Chantix (varenicline) and Zyban…

FDA provides consumers and industry with safety, regulatory and availability information for various drugs by drug class. From A to…

Frequently Asked Questions About Therapeutic Biological Products

This page provides summaries of past DSB Meetings. Each summary include DSCs posted since the last meeting, topics presented and…

Discover FDA-approved products for anthrax preparedness and response. Get essential information on vaccines, treatments, and preventive measures to protect public…

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

Stay informed on FDA updates and press announcements about recalls involving angiotensin II receptor blockers (ARBs) like valsartan and losartan.…

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

As part of the Accelerating Rare disease Cures (ARC) Program, CDER’s Rare Diseases Team inaugurated the Learning and Education to…

In collaboration with industry and the public, FDA creates an annual list of regulatory science initiatives on generic drugs.