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Congress Passes FDA User-Fee Legislation to Address Drug Shortages

Both chambers of Congress have passed the Food and Drug Administration (FDA) Safety and Innovation Act (S. 3187) to reauthorize the Prescription Drug User Fee Act and Medical Device User Fee and Modernization Act and create user fees to support the FDA review and inspection process for companies seeking approval for generic and biologically similar drugs. The House passed the bill on June 20, and the Senate followed suit on June 26.

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