U.S. Food and Drug Administration • Center for Drug Evaluation and Research
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October 15, 2002
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The Federal Government: Recent Changes at FDA and the Implications for Pediatric Clinical Trials
Why the increased concern about children in research?
Children in Research
Overview
Historical Perspective
"Off-label" use
Is "Off-label" use bad?
"There is a moral imperative to formally study drugs in children so that they can enjoy equal access to existing as well as new therapeutic agents." PEDIATRICS Vol. 95 No. 2 February 1995
Benchmarks Pediatric Drug Development
New Legislation BPCA
BPCA
What has happened as a result of the legislation?
Progress: Industry Response as of September 2002
Progress: Studies Requested as of September 2002
Progress: Pediatric Rule Update April 1999 - March 2002
How have these studies impacted children?
Progress: Health Impact of 1997 FDAMA
Progress: Product Labeling with Significant Changes for Dosing or Risk
What have we learned?
Ethical Issues
FDA Ethics Working Group Consensus Statement on the Pediatric Advisory Subcommittee’s November 15, 1999 Meeting (Patients vs. subjects in pediatric trials)
Pediatric Advisory Subcommittee’s November 15, 1999 FDA Ethics Working Group Consensus Statement on the Meeting (Patients vs. subjects in pediatric trials continued)
General Principles
To Find out More
Background Slides
Progress: Identification of a Safety and Effectiveness Issue
Progress: Products with Labeling Changes as of September 2002
Progress: Products with Labeling Changes as of September 2002 (continued)
DRAFT: Pediatric Advisory Subcommittee Meeting April 24, 2001
DRAFT Proposed Consensus Areas (cont’d.)
Rosemary Roberts, M.D.
Deputy Director
Office of Counter-Terrorism and Pediatric Drug Development
Center for Drug Evaluation and Research
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FDA/Center for Drug Evaluation and Research Last Updated: October 23, 2002 Originator: OCTAP/DPDD HTML by MAU
