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2004D-0187:
Guidance for Industry on Premarketing Risk Assessment
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| Document #
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| Received Date
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| Filed
Date
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| Submitter Code
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| Submitter
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| FR
Date
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| FR
Page
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| Comment Date
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| Files
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| Remarks
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| GDL1
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| 05/04/2004
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| 05/04/2004
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| Federal
Government
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| Guideline
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| pdf
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| Signature:
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| Guideline
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| NAD1
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| 05/04/2004
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| FDA
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| FDA
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| 05/05/2004
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| 25130-25132
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| 07/06/2004
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| pdf
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| Signature:
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| SHUREN, JEFFREY
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| EMC1
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| 05/17/2004
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| 05/17/2004
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| Individual Consumer
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| T. Scherer
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| C1
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| 06/03/2004
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| 05/30/2004
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| Private Industry
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| Risk Management Resources
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| pdf
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| Signature:
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| Felix M. Arellano, MD
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| C2
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| 06/29/2004
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| 06/28/2004
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| Drug Industry
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| Aventis Pharmaceuticals,
Inc.
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| pdf
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| Signature:
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| Steve Caffe, MD
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| EMC2
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| 07/02/2004
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| 07/02/2004
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| Device Industry
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| Biotechnology Industry
Organization (BIO)
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| pdf
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| Signature:
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| Sara Radcliffe
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| EC1
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| 07/01/2004
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| 06/30/2004
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| Federal
Government
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| FDA/OPaSS
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| pdf
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| Signature:
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| McNeil, Melodi
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| EC2
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| 07/03/2004
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| 07/02/2004
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| Drug Industry
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| Eli Lilly and Company
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| pdf
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| Signature:
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| Hyslop, David
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| EC3
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| 07/03/2004
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| 07/02/2004
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| Health Professional
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| University of Pennsylvania
School of Medicine
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| pdf
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| Signature:
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| Hennessy, Sean
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| C3
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| 07/07/2004
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| 07/06/2004
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| Drug Industry
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| Hoffman-LaRoche, Inc.
(Roche)
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| pdf
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| Signature:
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| Susan P. Ackermann Shiff, PhD
and C
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| C4
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| 07/07/2004
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| 07/06/2004
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| Drug Industry
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| Novartis Pharmaceuticals,
Corp. (Novartis)
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| pdf
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| Signature:
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| Judith M. Sills, PharmD
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| C5
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| 07/07/2004
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| 07/06/2004
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| Drug Industry
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| Wyeth Pharmaceuticals
(Wyeth)
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| pdf
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| Signature:
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| D. Bruce Burlington, M.D.
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| C6
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| 07/06/2004
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| 07/06/2004
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| Drug Industry
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| Abbott Laboratories
(Abbott)
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| pdf
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| Signature:
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| Douglas L. Sporn
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| C7
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| 07/06/2004
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| 07/06/2004
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| Drug Industry
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| Pharmaceutical Research and Manufacturers of America (PhRMA)
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| pdf
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| Signature:
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| Alan Goldhammer, PhD
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| C8
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| 07/02/2004
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| 07/01/2004
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| Drug Industry
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| AstraZeneca Pharmaceuticals,
LP
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| pdf
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| Signature:
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| Gary Horowitz
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| EMC3
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| 07/06/2004
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| 07/06/2004
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| Private Industry
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| Centers
for Education & research on Therapeutics (CERTs)
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| pdf
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| Signature:
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| Robert M. Califf, MD
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| EMC4
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| 07/06/2004
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| 07/06/2004
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| Drug Industry
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| Merck & Co., Inc.
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| pdf
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| Signature:
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| Donald M. Black,MD,MBA
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| EMC5
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| 07/06/2004
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| 07/06/2004
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| Drug Industry
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| Johnson and Johnson
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| pdf
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| Signature:
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| Janice K. Bush, MD
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| C9
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| 07/08/2004
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| 07/02/2004
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| Private Industry
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| ISPE
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| pdf
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| Signature:
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| Judith K. Jones,MD,PhD,FISPE
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Top | Up
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Page last updated
July 20, 2005
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