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United States · Law · HR

H.R. 3580 (110th)

Food and Drug Administration Amendments Act of 2007

enactedUnited States· United States Congress· EN

Introduced

19 September 2007

Last action

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Status

Became Public Law No: 110-85.

Sponsors

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Subjects

Discovery layer

Source updated

7 April 2025

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Summary

Food and Drug Administration Amendments Act of 2007 - Prescription Drug User Fee Amendments of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to reauthorize the collection of prescription drug user fees for FY2008-FY2012. Requires the Secretary of Health and Human Services to assess and collect fees for advisory review of direct-to-consumer television advertisements of prescription drugs. Medical Device User Fee Amendments of 2007 - Reauthorizes the collection of medical device user fees for FY2008-FY2012. Sets forth provisions governing the inspection of medical device establishments by accredited persons. Pediatric Medical Device Safety and Improvement Act of 2007 - Requires a person that submits an application for approval of a medical device to provide information on pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure. Pediatric Research Equity Act of 2007 - Sets forth conditions under which the Secretary may grant waivers or deferrals of requirements that applicants submit a pediatric assessment for new drugs and biological products. Best Pharmaceuticals for Children Act of 2007 - Makes changes to provisions regarding market exclusivity for conducting pediatric drug studies on new or already approved drugs. Establishes the Reagan-Udall Foundation for the Food and Drug Administration as a nonprofit corporation to advance the mission of the Food and Drug Administration (FDA) to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety. Provides for recruitment of potential members of FDA advisory committees. Requires the Secretary, acting through the Director of the National Institutes of Health (NIH), to expand the clinical trials registry data bank. Authorizes the Secretary to require a responsible person for a drug to conduct a postapproval study on the basis of appropriate scientific data. Requires the Secretary to: (1) develop ingredient, processing, and labeling standards for pet foods; and (2) establish a Reportable Food Registry. Requires the Secretary, acting through the Commissioner of Food and Drugs, to identify and make public clinically susceptible concentrations of antimicrobials.

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Documents

12 official files

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