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.

Medical laws and legislation.

Product safety.

Physical Description:

1 online resource

Contained In:

ProQuest U.S. Congressional Research Digital Collection

Place of Publication:

[Place of publication not identified] [publisher not identified] 2007

Summary:

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

Notes:

CRS Report

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

Vendor supplied data

Other Format:

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

Publisher Number:

CRS-2007-DSP-0537

Access Restriction:

Restricted for use by site license