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

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Title

Main Title FDA’s Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective

Creator

Expert: Thaul, Susan

Creator Type: Personal

Creator Info: Specialist in Drug Safety and Effectiveness

Publisher

Name: Library of Congress. Congressional Research Service.

Place of Publication: Washington D.C.

Date

Creation: 2012-06-25

Language

English

Description

Content Description: The report describes why research on a drug's pharmacokinetics, safety, and effectiveness in children might be necessary. This report then presents why the marketplace has not provided sufficient incentives to manufacturers of drugs approved for adult use to study their effects in children. It also analyzes the impact of BPCA and PREA have had on pediatric drug research.
Physical Description: 28 p.

Subject

Legislative Subject Terms: Food and Drug Administration (FDA)

Collection

Name: Congressional Research Service Reports

Code: CRSR

Institution

Name: UNT Libraries Government Documents Department

Code: UNTGD

Rights

Rights License: pd

Resource Type

Report

Format

Text

Identifier

CRS Report Number: RL33986
Accession or Local Control No: RL33986_2012Jun25
Archival Resource Key: ark:/67531/metadc818833