Table of Contents
Adequacy of Current Laws Governing Research in Children:
The View from FDA
Overview
Historical Perspective
“Off-Label” Use
Is “Off-Label” Use Bad?
Benchmarks:
Pediatric Drug Development
New Legislation:
BPCA
New Legislation:
BPCA
Why the Increased Concern about
Children in Research?
Progress: Industry Response and Health Impact of 1997 FDAMA as of February 2002
Progress: Studies Requested
as of February 2002 (1997 FDAMA)
Progress: Pediatric Rule Update
April 1999 - December 2001
Peds Rule Studies Completed
What have we learned?
Ethical Issues
Ethical Issues
Ethical Issues
FDA Ethics Working Group Consensus
Statement on the Pediatric Advisory Subcommittee’s November 15, 1999 Meeting (Patients vs.
subjects in pediatric trials)
FDA Ethics Working Group Consensus Statement on the Pediatric Advisory Subcommittee’s November 15, 1999 Meeting (Patients vs.
subjects in pediatric trials), cont'd
FDA Ethics Working Group Consensus Statement on the Pediatric Advisory Subcommittee’s September 11, 2000 Meeting
(placebo controlled trials)
FDA Ethics Working Group Consensus Statement on the Pediatric Advisory Subcommittee’s September 11, 2000 Meeting
(placebo controlled trials), cont'd
DRAFT:
Pediatric Advisory Subcommittee
Meeting April 24, 2001; Proposed Consensus Areas
DRAFT
Proposed Consensus Areas, cont’d
DRAFT
Proposed Consensus Areas cont’d
General Principles
To Find out More
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Author:
Rosemary Roberts, M.D.
Office of Pediatric Drug Development and Program
Initiatives
Center for Drug Evaluation and Research
Food and Drug Administration
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