TITLE

Pediatric Mandate

AUTHOR(S)
Keeney, Ronald
PUB. DATE
April 2001
SOURCE
Pharmaceutical Executive;Apr2001, Vol. 21 Issue 4, p98
SOURCE TYPE
Trade Publication
DOC. TYPE
Article
ABSTRACT
Explores how the pharmaceutical industry of the United States (U.S.) can change its approach to pediatric clinical trials in line with the U.S. Food and Drug Administration's (FDA) regulations mandating pediatric studies for drugs and biologicals. FDA initiatives in line with the issue of pediatric labeling and clinical trials; Meeting the FDA mandate; Challenges faced by the industry related to pediatric studies and labeling mandate of the FDA. INSET: Getting Started.
ACCESSION #
4341894

 

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