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The Role of the FDA in Pediatric Research
Presented July 16, 2004
Overview
The Food and Drug Administration
FDA Impact
Drug Development in under 15 minutes
Acronyms
New Drug Development
Investigators’ Interactions with FDA
FDA’s Bioresearch Monitoring Program
Site Selection: General Caveats
Mechanics of On-Site FDA BiMo Clinical Investigator Inspections
Compliance Classifications
Pediatric Specific Activities
Written Request (WR)
BPCA- Provisions
FDA On-Patent Drug Exclusivity Process
FDA/NIH Off-Patent Drug Process
Goal
Labeling – the Best and the Worst
Labeling Intent
Labeling Problems
Labeling
The Knowledge Gap in Pediatric Therapeutics
The Knowledge Gap: Possible Reasons
Pediatric Benchmarks
History of Pediatric Regulations/Legislation
2002 Best Pharmaceuticals for Children Act (BPCA)
Best Pharmaceuticals for Children Act (cont.)
Results, Lessons Learned & Issues
Results
RESULTS, June, 2004
Exclusivity: On-Patent Summary of Important Findings
Gabapentin Descriptors on Studies
Growth and Development
Cognition and Behavior
Progress: Product Labeling with Significant Changes for Dosing or Risk
Progress: Identification of a Safety and Effectiveness Issue
Bridging Studies in Drug Development (for Different Scenarios)
Definition of Bridging Studies
Additional Intrinsic & Extrinsic Factors Defined in ICG E5
Example 1: Pediatric Bridging
Pediatric Study Decision Tree
Studies in Pediatrics with SVT/VT
PK in Pediatrics
Lessons Learned
What Have We Learned
ONGOING LESSONS LEARNED
Ethical Issues
General Principles ICH E-11
Prior Peds Advisory Subcommittee Discussion
Prior Peds Advisory Subcommittee Discussion (cont.)
FDA Web Page
Pediatric Web Page
To Contact Us
Future Research
Back-up
Pharmacometrics
Consensus Statement-1999
Consensus Statement-1999 (cont.)
Consensus Statement-2000
Consensus Statement-2000 (cont.)
Consensus Statement-2001
Consensus Statement-2001 (cont.)
Presented: July 16, 2004 Glaser Pediatric Research Network Symposium
Download presentation source [PowerPoint format]
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Date created: September 2, 2004
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