The FDA Drug Approval Process: Focus on Pediatric Labeling

Gretchen Brummel

doi:10.1891/0730-0832.20.3.49

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The FDA Drug Approval Process: Focus on Pediatric Labeling

Journal article

Peer reviewed

The FDA Drug Approval Process: Focus on Pediatric Labeling

Gretchen Brummel

Neonatal network, Vol.20(3), pp.49-51

04/2001

DOI: 10.1891/0730-0832.20.3.49

PMID: 12144214

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Abstract

MANY HEALTHCARE professionals are not familiar with the current Food and Drug Administration (FDA) drug approval process, especially with regard to the system's impact on pediatric patients. This column reviews the definition of pediatric labeling and its importance in the treatment of children, the history of drug regulation legislation, and the current drug approval process, proposes explanations for the deficit in pediatric labeling, and describes the steps that have been taken to correct this deficit.

Advanced Practice

Critical Care, Acute Care, and Emergency

Nursing

Pediatrics and Neonatal

Women's Health, Obstetrics, and Midwifery

Details

Title: Subtitle: The FDA Drug Approval Process: Focus on Pediatric Labeling
Creators: Gretchen Brummel - Penn State Milton S. Hershey Medical Center
Resource Type: Journal article
Publication Details: Neonatal network, Vol.20(3), pp.49-51
Publisher: Springer Publishing Company
DOI: 10.1891/0730-0832.20.3.49
PMID: 12144214
ISSN: 0730-0832
eISSN: 1539-2880
Number of pages: 3
Language: English
Date published: 04/2001
Academic Unit: Pharmacy Practice and Science
Record Identifier: 9984772263602771

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