Long title | To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs, and for other purposes. |
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Enacted by | the 110th United States Congress |
Effective | September 27, 2007 |
Citations | |
Public law | 110-85 |
Statutes at Large | 121 Stat. 823 |
Codification | |
Acts amended | Federal Food, Drug and Cosmetic Act |
Titles amended | 21 U.S.C.: Food and Drugs |
U.S.C. sections amended | 301 |
Agencies affected | Food and Drug Administration |
Legislative history | |
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President of the United States George W. Bush signed the Food and Drug Administration Amendments Act of 2007 (FDAAA) on September 27, 2007. This law reviewed, expanded, and reaffirmed several existing pieces of legislation regulating the FDA. These changes allow the FDA to perform more comprehensive reviews of potential new drugs and devices.[1] It was sponsored by Reps. Joe Barton and Frank Pallone and passed unanimously by the Senate.[2]
The FDAAA extended the authority to levy fees to companies applying for approval of drugs, expanded clinical trial guidelines for pediatric drugs, and created the priority review voucher program, amongst other items.