U.S. Food and Drug Administration • Center for Drug Evaluation and Research
Pediatrics
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What’s So Special About Children?
Historical perspective
Historical perspective (cont’d)
Labeling Requirement [44FR, 6/26/79]
“Off-Label” Use
Is “Off-label” use bad?
Why?
Children are a work in progress
Children: Special Organ System Maturation
Age-related effects on GFR in pediatrics and elderly relative to adults [graph]
Age-related effects on CYP450 activity in pediatrics and elderly relative to adults [graph]
Growth and development can affect drug disposition and action
Consequences of “Off-label” use
Concerns
Toxicity
Years of “experimentation” have resulted in enough experience to allow for the safe and effective use for drugs such as the penicillins and aminoglycosides
Pediatric Drug Development
1994 Pediatric Rule
2 Major Initiatives
FDAMA - Sec. 111
Response to Pediatric Exclusivity As of October 2001
Types of Studies Requested As of October 2001
Health Impact of New Labels
Product Labeling with Significant Changes for Dosing or Risk
Report to Congress
1998 Final Rule
Important Points of the Rule
1998 Final Rule 4/99-6/01
Final Rule vs. FDAMA
Pediatric initiatives are driving pediatric drug development
Pediatric studies - Key questions:
Preclinical considerations re: juvenile animal studies
Juvenile animal studies
Examples
Preclinical studies requested
To find out more
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FDA/Center for Drug Evaluation and Research Last Updated: February 27, 2002 Originator: OND/OPDDPI HTML by MAU
