Effective September 27, 2007 Statutes at Large 121 Stat. 823 | Public law 110-85 | |
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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. Acts amended Federal Food, Drug and Cosmetic Act |
President of the United States George W. Bush signed the Food and Drug Administration Amendments Act of 2007 (FDAAA), 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.
Contents
- Prescription Drug User Fee Act
- Medical Device User Fee and Modernization Act MDUFMA
- Best Pharmaceuticals for Children Act BPCA
- Pediatric Research Equity Act PREA
- Priority review to encourage treatments for tropical diseases
- Reagan Udall foundation
- Advisory committee conflicts of interest
- Clinical trials reporting
- References
Prescription Drug User Fee Act
The Prescription Drug User Fee Act (PDUFA) (IV) was first enacted in 1992 to allow the FDA to collect “user fees” from biotechnology and pharmaceutical companies. Since then, it has been reauthorized three times; first in 1997, then 2002, and most recently with the passage of the FDAAA in 2007.
The purpose of these fees is to provide resources to the FDA that help them more effectively review potential new drugs.The most recent reauthorization will further expand on the previous policy. It aims to broaden and upgrade the drug safety program, allocate more resources for television advertising, and theoretically allow the FDA to more efficiently review and approve safe and effective new drugs for consumers.
Medical Device User Fee and Modernization Act (MDUFMA)
Best Pharmaceuticals for Children Act (BPCA)
Pediatric Research Equity Act (PREA)
Priority review to encourage treatments for tropical diseases
Reagan-Udall foundation
Advisory committee conflicts of interest
Clinical trials reporting
The FDAAA also requires registration and reporting of basic results of clinical trials of medicines and devices subject to FDA regulation on the freely-accessible site ClinicalTrials.gov.