FDA's Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective.

Format:

Book

Government document

Author/Creator:

Library of Congress. Congressional Research Service.

Language:

English

Subjects (All):

Children.

Drugs.

Labels.

Manufactures.

Physical Description:

1 online resource (1 online resource (28 p), digital, PDF file)

monochrome

Place of Publication:

[Place of publication not identified] : [publisher not identified], 2012.

System Details:

text file

Summary:

This report is one in a series of updates. For the most recent coverage of this report series, please see 07-RL-33986a in the 2007 issue.

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. Discusses drug effects in children and why manufacturers have not tested most drugs in children. Reviews issues for reauthorization of BPCA and PREA, including relationship between BPCA and PREA, costs and benefits of pediatric marketing exclusivity, labeling, challenge of measuring impact on pediatric drug research, and enforcement.

Notes:

Record is based on bibliographic data in ProQuest U.S. Congressional Research Digital Collection (last viewed Apr. 2014). Reuse except for individual research requires license from ProQuest, LLC.

CRS Report.

Other Format:

Microfiche version: Library of Congress. Congressional Research Service. FDA's Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective

Access Restriction:

Restricted for use by site license.