Food and Drug Administration Safety and Innovation Act

Food and Drug Administration Safety and Innovation Act

by Senate and House of Representatives of the United States of America in Congress assembled

188 pages· 2012
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An Act To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes.

‘‘Prescription Drug User Fee Amendments of 2012’’.

‘‘Medical Device User Fee Amendments of 2012’’.

‘‘Generic Drug User Fee Amendments of 2012’’.

‘‘Biosimilar User Fee Act of 2012’’.

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