GDUFA and BsUFA User Fees | Association for Accessible Medicines
AAM All Access Podcast - AAM CEO Dan Leonard convenes industry and policy experts to explore why the Inflation Reduction Act (f/k/a Build Back Better) reduces generic and biosimilar competition.

GDUFA and BsUFA User Fees

What are GDUFA and BsUFA user fees? Watch this this video to learn more about how the Generic Drug User Fee Amendments (GDUFA) and Biosimilar User Fee Act (BsUFA) help to get more generic and biosimilar medicines to patients more quickly. Over ten years, the generic and biosimilar industry has provided the FDA over $4 billion for review and approval of lower-cost treatments for America’s patients. The result is more than $2 trillion in savings to patients and a dramatic increase in patient access to life-saving treatments.

 

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