FDA's Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective [electronic resource].
- Corporate Author:
- Library of Congress. Congressional Research Service
- [Place of publication not identified] : [publisher not identified], 2007.
- Physical Description:
- 23 pages : digital, PDF file
- Provides background on the development of P.L. 107-109, the Best Pharmaceuticals for Children Act (BPCA), and P.L. 108-155, the Pediatric Research Equity Act (PREA), both of which allow the FDA to offer financial and regulatory incentives to drug manufacturers for testing their products for pediatric use. Examines issues leading up to the enactment of BPCL and PREA, including manufacturer reluctance to test drugs in children; reviews provisions of BPCL and PREA; and highlights relevant laws and regulations preceding these acts. Discusses impact of BPCA and PREA on pediatric drug research, Congressional options, and recent legislation.
- Related Titles:
- ProQuest U.S. Congressional Research Digital Collection
- Record is based on bibliographic data in ProQuest U.S. Congressional Research Digital Collection (last viewed Dec. 2010). Reuse except for individual research requires license from ProQuest, LLC., CRS Report., and AVAILABLE ONLINE TO AUTHORIZED PSU USERS.
- Technical Details:
- System requirements: PDF reader software.
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