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Adequacy of Current Laws Governing Research in Children:
The View from FDA

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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

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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Last Updated: May 22, 2002
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