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Food and Drug Administration Amendments Act of 2007: Difference between revisions
Food and Drug Administration Amendments Act of 2007 (view source)
Revision as of 01:55, 11 February 2025
, 11 FebruaryText replacement - "George W. Bush" to "George W. Bush"
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| agreeddate4= September 20, 2007 | | agreeddate4= September 20, 2007 | ||
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| signedpresident = | | signedpresident = George W. Bush | ||
| signeddate = September 27, 2007 | | signeddate = September 27, 2007 | ||
| amendments = | | amendments = | ||
| SCOTUS cases = | | SCOTUS cases = | ||
}} | }} | ||
[[President of the United States]] | [[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.<ref>{{cite web|url=https://www.fda.gov/oc/initiatives/advance/fdaaa.html|title=Law Strengthens FDA<!-- Bot generated title -->|website=[[Food and Drug Administration]]|publisher=}}</ref> It was sponsored by Reps. [[Joe Barton]] and [[Frank Pallone]] and passed unanimously by the Senate.<ref>{{cite web|url=https://www.congress.gov/bill/110th-congress/house-bill/3580/cosponsors|title=Cosponsors - H.R.3580 - 110th Congress (2007-2008): Food and Drug Administration Amendments Act of 2007|first=Dingell|last=John|date=27 September 2007|website=www.congress.gov}}</ref> | ||
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. | 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. | ||