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| Document #
|
| Received Date
|
| Filed
Date
|
| Submitter Code
|
| Submitter
|
| FR
Date
|
| FR
Page
|
| Comment Date
|
| Files
|
| Remarks
|
|
|
|
|
| NM1
|
|
|
| 01/11/2007
|
| FDA
|
| FDA
|
| 01/16/2007
|
| 1743-1753
|
| 02/23/2007
|
| htm pdf
|
| Registration due 2/2/2007
|
|
| Signature:
|
| Jeffrey Shuren
|
|
|
| EC1
|
| 01/19/2007
|
| 01/16/2007
|
| Drug Industry
|
| Strides Inc.
|
|
|
|
|
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|
| htm
|
|
|
|
| Signature:
|
| Riebling, Peter
|
|
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| LST1
|
| 02/13/2007
|
| 02/13/2007
|
| Federal Government
|
| Agenda for February 16, 2007 Public Meeting
|
|
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|
| htm
|
|
|
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|
| TS1
|
| 02/20/2007
|
| 02/20/2007
|
| Federal Government
|
| Prescription Drug User Fee Act (PDUFA IV)
|
|
|
|
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|
| pdf
ppt
|
|
|
|
|
|
| TS2
|
| 02/20/2007
|
| 02/20/2007
|
| Federal Government
|
| FDA - User-Fee Funding of Human Drug Review
|
|
|
|
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| pdf
ppt
|
| Reauthorization of the Prescription Drug User Fee Act
|
|
|
|
| Signature:
|
| Janet Woodcock, MD
|
|
|
|
|
| TS3
|
| 02/20/2007
|
| 02/20/2007
|
| Individual Consumer
|
| K Witczak
|
|
|
|
|
|
|
| pdf
|
| Testimony
|
|
|
| TS4
|
| 02/20/2007
|
| 02/20/2007
|
| Consumer Group
|
| Consumers Union
|
|
|
|
|
|
|
| pdf
|
| Testimony
|
|
| Signature:
|
| William Vaughan
|
|
|
| TS5
|
| 02/20/2007
|
| 02/20/2007
|
| Association
|
| Plasma Protein Therapeutics Association (PPTA)
|
|
|
|
|
|
|
| pdf
|
| Testimony
|
|
| Signature:
|
| Mary Gustafson
|
|
|
| TS6
|
| 02/20/2007
|
| 02/20/2007
|
| Association
|
| U S Chamber of Commerce
|
|
|
|
|
|
|
| pdf
|
| Testimony
|
|
|
|
| Signature:
|
| Anthony C Wisniewsky
|
|
|
|
| TS7
|
| 02/20/2007
|
| 02/20/2007
|
| Consumer Group
|
| Committee of Ten Thousand
|
|
|
|
|
|
|
| pdf
|
| Testimony
|
|
| Signature:
|
| David Cavenaugh
|
|
|
| TS8
|
| 02/20/2007
|
| 02/20/2007
|
| Association
|
| AHRP
|
|
|
|
|
|
|
| pdf
|
| Testimony
|
|
| Signature:
|
| Ellen Liversidge
|
|
|
| TS9
|
| 02/20/2007
|
| 02/20/2007
|
| Association
|
| Coalition for Healthcare Communication
|
|
|
|
|
|
|
| pdf
ppt
|
| Testimony
|
|
| Signature:
|
| John Kamp
|
|
|
| TS10
|
| 02/20/2007
|
| 02/20/2007
|
| Private Industry
|
| Biotechnology Industry Organization
|
|
|
|
|
|
|
| pdf
ppt
|
| Testimony
|
|
| Signature:
|
| Alison Lawton
|
|
|
| TS11
|
| 02/20/2007
|
| 02/20/2007
|
| Private Industry
|
| Academy of Managed Care Pharmacy
|
|
|
|
|
|
|
| pdf
ppt
|
| Testimony
|
|
| Signature:
|
| Judith A Cahill
|
|
|
| TS12
|
| 02/20/2007
|
| 02/20/2007
|
| Private Industry
|
| Drug Safety Institute
|
|
|
|
|
|
|
| pdf
ppt
|
| Testimony
|
|
| Signature:
|
| Lil Stiver RPh
|
|
|
| TS13
|
| 02/20/2007
|
| 02/20/2007
|
| Private Industry
|
| Biotechnology Industry Organization
|
|
|
|
|
|
|
| pdf
|
| Testimony
|
|
|
| TS14
|
| 02/20/2007
|
| 02/20/2007
|
| Consumer Group
|
| National Research Center for Women & Families
|
|
|
|
|
|
|
| pdf
|
| Testimony
|
|
| Signature:
|
| Diana Zuckerman PhD
|
|
|
| TS15
|
| 02/21/2007
|
| 02/21/2007
|
| Association
|
| American Society of Health-Systems Pharmacists
|
|
|
|
|
|
|
| html
pdf
|
| Testimony
|
|
| Signature:
|
| Brian M Meyer
|
|
|
| TS16
|
| 02/21/2007
|
| 02/21/2007
|
| Private Industry
|
| Mental Health America
|
|
|
|
|
|
|
| html
pdf
|
| Testimony
|
|
| Signature:
|
| David Fassler
|
|
|
|
|
| TS17
|
| 02/21/2007
|
| 02/21/2007
|
| Private Industry
|
| Council on Radionuclides and Radiopharmaceuticals (CORAR)
|
|
|
|
|
|
|
| html
pdf
|
| Testimony
|
|
| Signature:
|
| Alan Kirschenbaum
|
|
|
| TS18
|
| 02/21/2007
|
| 02/21/2007
|
| Individual Consumer
|
| W DeCamp
|
|
|
|
|
|
|
| html
pdf
|
| Testimony
|
|
|
| SUP1
|
| 02/22/2007
|
| 02/22/2007
|
| Association
|
| Coalition for Healthcare Communication
|
|
|
|
|
|
|
| pdf
|
| Revised Testimony
|
|
| Signature:
|
| John Kamp
|
|
|
| TS19
|
| 02/22/2007
|
| 02/22/2007
|
| Association
|
| Pharmaceutical Research and Manufacturers of America (PhRMA)
|
|
|
|
|
|
|
| pdf
|
| Testimony
|
|
| Signature:
|
| Alan Goldhammer, PhD
|
|
|
|
| TS20
|
| 02/22/2007
|
| 02/22/2007
|
| Individual Consumer
|
| Parkinson Pipeline Project
|
|
|
|
|
|
|
| html
pdf
|
| Testimony - A Patient's Perspective on Key Policy Issues for User Fees and Drug Safety Legislation
|
|
| Signature:
|
| Perry D Cohen PhD
|
|
|
|
|
|
| EC2
|
| 02/22/2007
|
| 02/19/2007
|
| Consumer Group
|
| Consumers Union
|
|
|
|
|
|
|
| htm
|
| No attachment received
|
|
| Signature:
|
| Vaughan, William
|
|
|
| EC3
|
| 02/22/2007
|
| 02/20/2007
|
| Health Care Association
|
| ISPE
|
|
|
|
|
|
|
| htm
|
|
|
|
|
|
| Signature:
|
| Epstein, Mark
|
|
|
|
| EC4
|
| 02/22/2007
|
| 02/21/2007
|
| Health Professional
|
| Dr. Alan Wasserman
|
|
|
|
|
|
|
| htm
|
|
|
|
|
| TS21
|
| 02/23/2007
|
| 02/23/2007
|
| Association
|
| Friends of Cancer Research
|
|
|
|
|
|
|
| pdf
|
| Testimony
|
|
| Signature:
|
| Jeff Allen PhD
|
|
|
| C1
|
| 02/23/2007
|
| 02/22/2007
|
| Association
|
| National Health Council
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Marc Boutin
|
|
|
| EC5
|
| 02/26/2007
|
| 02/22/2007
|
| Health Care Association
|
| American College of Clinical Pharmacy
|
|
|
|
|
|
|
| htm
|
|
|
|
|
| Signature:
|
| McGlew, John
|
|
|
|
| EC6
|
| 02/26/2007
|
| 02/22/2007
|
| Other Organization
|
| AARP
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Certner, David
|
|
|
| EC13
|
| 02/26/2007
|
| 02/23/2007
|
| Association
|
| American Association of Colleges of Pharmacy
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Lang, William
|
|
|
| EC14
|
| 02/26/2007
|
| 02/23/2007
|
| Drug Association
|
| Pharm Res & Mfrs of America
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Goldhammer, Alan
|
|
|
| EC15
|
| 02/26/2007
|
| 02/23/2007
|
| Health Professional
|
| National Alliance of Medical Researchers
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Charles, David
|
|
|
| EC16
|
| 02/26/2007
|
| 02/23/2007
|
| Consumer Group
|
| National Alliance on Mental Illness
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Sperling, Andrew
|
|
|
| EC17
|
| 02/26/2007
|
| 02/23/2007
|
| Health Care Association
|
| National Organization for Rare Disorders (NORD)
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Meyers, Abbey
|
|
|
|
| EC18
|
| 02/26/2007
|
| 02/23/2007
|
| Health Care Association
|
| American Pharmacists Association (APhA)
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Gans, John
|
|
|
|
| EC19
|
| 02/26/2007
|
| 02/23/2007
|
| Health Care Association
|
| National Organization for Rare Disorders (NORD)
|
|
|
|
|
|
|
|
|
| No Attachment received
|
|
|
| Signature:
|
| Meyers, Abbey
|
|
|
|
|
| EC20
|
| 02/26/2007
|
| 02/23/2007
|
| Consumer Group
|
| CENTER FOR MEDICAL CONSUMERS
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| LEVIN, ARTHUR
|
|
|
| EC21
|
| 02/26/2007
|
| 02/23/2007
|
| Academia
|
| University of Pennsylvania CERT
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Hennessy, Sean
|
|
|
| EC22
|
| 02/26/2007
|
| 02/23/2007
|
| Drug Industry
|
| Council on Radionuclides and Radiopharmaceuticals
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Kirschenbaum, Alan
|
|
|
| EC23
|
| 02/26/2007
|
| 02/23/2007
|
| Consumer Group
|
| National Consumers League
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Golodner , Linda
|
|
|
| EC24
|
| 02/26/2007
|
| 02/23/2007
|
| Consumer Group
|
| FasterCures
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Simon, Greg
|
|
|
| EC25
|
| 02/26/2007
|
| 02/23/2007
|
| Other Organization
|
| Elizabeth Glaser Pediatric AIDS Foundation
|
|
|
|
|
|
|
| Attachments: 1.pdf, 2.pdf
|
|
|
|
| Signature:
|
| Thompson, Diane
|
|
|
| EC26
|
| 02/26/2007
|
| 02/23/2007
|
| Consumer Group
|
| Ms. Margaret Anderson
|
|
|
|
|
|
|
|
|
| No attachment received
|
|
|
| EC27
|
| 02/26/2007
|
| 02/23/2007
|
| Health Care Association
|
| The ALS Association
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Gibson, Steve
|
|
|
|
|
| EC28
|
| 02/26/2007
|
| 02/23/2007
|
| Other Organization
|
| National Research Center for Women & Families
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Zuckerman, Diana
|
|
|
| C2
|
| 02/26/2007
|
| 02/26/2007
|
| Private Industry
|
| Sepracor
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Stewart H. Mueller
|
|
|
| C3
|
| 03/01/2007
|
| 02/27/2007
|
| Private Industry
|
| Pain Therapeutics, Inc.
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Stephen E. Johnson
|
|
|
| C4
|
| 02/27/2007
|
| 02/23/2007
|
| Association
|
| American Association of Colleges of Pharmacy
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| William G. Lang, M. P. H.
|
|
|
| TS22
|
| 02/26/2007
|
| 02/26/2007
|
| Association
|
| ALS Association
|
|
|
|
|
|
|
| htm | pdf
|
|
|
|
| Signature:
|
| Steve Gibson
|
|
|
| TS23
|
| 02/26/2007
|
| 02/26/2007
|
| Association
|
| National Alliance on Mental Illness (NAMI)
|
|
|
|
|
|
|
| htm | pdf
|
|
|
|
| Signature:
|
| Michael J. Fitzpatrick, M.S.W.
|
|
|
| EMC1
|
| 03/02/2007
|
| 02/26/2007
|
| Association
|
| American Heart Association
|
|
|
|
|
|
|
| htm | pdf
|
|
|
|
| Signature:
|
| Andrew B Buroker Esq, Raymond L G
|
|
|
| EMC2
|
| 03/06/2007
|
| 02/23/2007
|
| Association
|
| Union of Concerned Scientists
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Farncesca T Grifo PhD
|
|
|
|
|