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2005N-0410:
Prescription Drug User Fee Act (PDUFA): Public Meeting
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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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| NM1
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| 10/14/2005
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| FDA
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| FDA
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| 10/18/2005
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| 60536-60538
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| 12/14/2005
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| pdf
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| Public Meeting on
11/14/05
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| Signature:
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| Jeffrey Shuren
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| NCR1
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| 10/27/2005
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| FDA
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| FDA
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| 10/28/2005
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| 62126-62126
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| pdf
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| Signature:
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| SHUREN, JEFFREY
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| EC1
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| 11/08/2005
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| 11/04/2005
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| Academia
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| Dr. Iwan Darmansjah
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| htm
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| Signature:
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| Darmansjah, Iwan
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| EC2
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| 11/17/2005
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| 11/11/2005
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| Health Professional
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| Ms. Marie Cowie
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| htm
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| Signature:
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| Cowie, Marie
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| EC3
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| 11/17/2005
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| 11/14/2005
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| Federal Government
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| U.S. House of Representatives
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| Attachment
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| Signature:
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| Hinchey, Maurice
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| SUP1
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| 11/22/2005
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| 11/21/2005
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| Private Industry
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| Hyman, Phelps &
McNamara, P.C.
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| pdf
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| Signature:
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| Alan Kirschenbaum
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| LST1
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| 12/05/2005
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| 12/05/2005
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| Federal
Government
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| Agenda for
November 14, 25005 FDA and Stateholders Public Meeting
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| doc,
pdf
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| Signature:
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| Agenda for November 14, 25005
FDA
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| LST2
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| 12/05/2005
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| 12/05/2005
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| Federal
Government
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| Biographies for November
14, 2005 Meeting
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| doc,
pdf
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| Signature:
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| Biographies for November 14,
2005 M
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| TS1
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| 12/05/2005
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| 12/05/2005
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| Federal
Government
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| Deputy Commissioner
for Operations, FDA
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| htm,
pdf, ppt
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| Operation
of the Prescription Drug User Fee Program
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| Signature:
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| Janet Woodcock, MD
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| TS2
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| 12/05/2005
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| 12/05/2005
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| Federal
Government
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| Director,
Center for Drug Evaluation and Research, FDA
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| htm,
pdf,
ppt
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| Signature:
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| Steven Galson MD MPH
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| TS3
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| 12/05/2005
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| 12/05/2005
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| Federal
Government
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| Director,
Center for Biologics Evaluation and Research, FDA
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| htm,
pdf, ppt
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| Signature:
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| Jesse L Goodman MD MPH
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| TS4
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| 12/05/2005
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| 12/05/2005
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| Academia
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| Tufts University,
Tufts Center for the Study of Drug Development
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| htm,
pdf, ppt
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| Drug Development
Timelines and the Prescription Drug User Fee Act
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| Signature:
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| Kenneth I Kaitin, PhD
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| TS5
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| 12/05/2005
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| 12/05/2005
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| Academia
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| Critical Path Institute
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| pdf,
ppt
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| Creating
The Path for Innovative New Therapies
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| Signature:
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| Raymond L Woosley MD PhD
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| TS6
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| 12/05/2005
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| 12/05/2005
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| Academia
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| MIT Sloan
School and National Bureau of Econimic Research
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| htm,
pdf, ppt
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| PDUFA, Drug
Approval Times, Drug Safety Withdrawal Rates, and the Drug
Development Process: Empirical Findings
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| Signature:
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| Ernst Berndt PhD
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| TS7
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| 12/05/2005
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| 12/05/2005
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| Academia
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| Centers
for Education & Research on Therapeutics (CERTs)
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| htm,
pdf, ppt
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| AHRQ's Centers
for Education & Research on Therapeutics (CERTs):
A Partner for Drug Safety Surveillance
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| Signature:
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| Hugh H Tilson MD DrPH
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| TS8
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| 12/05/2005
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| 12/05/2005
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| Consumer Group
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| Parkinson Pipeline
Project
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| htm,
pdf, ppt
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| A patient's
perspective on user fees
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| Signature:
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| Perry D Cohen PhD
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Top | Up
| Next | Most Recent
Page last updated
December 29, 2005
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