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