| Up
2005D-0021:
INTERNATIONAL CONFERENCE ON HARMONISATION; DRAFT GUIDANCE ON Q8
PHARMACEUTICAL DEVELOPMENT
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Document #
|
| Received Date
|
| Filed
Date
|
| Submitter Code
|
| Submitter
|
| FR
Date
|
| FR
Page
|
| Comment Date
|
| Files
|
| Remarks
|
|
|
|
|
|
|
| GDL1
|
| 02/09/2005
|
| 02/09/2005
|
| Federal
Government
|
| Guidance
|
|
|
|
|
|
|
| doc,
pdf
|
|
|
|
|
|
| Signature:
|
| Guidance
|
|
|
|
|
|
|
|
| NAD1
|
|
|
| 02/09/2005
|
| FDA
|
| FDA
|
| 02/09/2005
|
| 6888-6889
|
| 04/11/2005
|
| pdf
|
|
|
|
|
| Signature:
|
| SHUREN, JEFFREY
|
|
|
|
|
| EC1
|
| 03/08/2005
|
| 03/07/2005
|
| Drug Industry
|
| GlaxoSmithKline
|
|
|
|
|
|
|
| htm,
Attachment
|
|
|
|
|
| Signature:
|
| Stokley, M.S.P.H.,
Anne
|
|
|
|
|
| C1
|
| 04/12/2005
|
| 04/11/2005
|
| Drug Industry
|
| Novartis Pharmaceuticals
Corporation (Novartis)
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Robert J. Clark
|
|
|
|
|
| C2
|
| 04/12/2005
|
| 04/11/2005
|
| Drug Industry
|
| Sanofi Aventis
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
|
| Signature:
|
| Steve Caffe, MD
|
|
|
| C3
|
| 04/12/2005
|
| 04/11/2005
|
| Drug Industry
|
| Genentech
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
|
| Signature:
|
| Robert L. Garnick,
PhD
| |
|
|
|
| C4
|
| 04/29/2005
|
| 04/29/2005
|
| Private Industry
|
| Jerussi Consulting,
Inc.
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Robert A. Jerussi, PhD
|
|
|
|
|
| EC2
|
| 05/02/2005
|
| 04/08/2005
|
| Drug Industry
|
| Berlex/Schering AG
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Hoover, James
|
|
|
|
|
| EC3
|
| 05/02/2005
|
| 04/08/2005
|
| Drug Industry
|
| Novartis Pharmaceuticals
Corporation
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Clark, Robert
|
|
|
|
|
| EC4
|
| 05/02/2005
|
| 04/11/2005
|
| Drug Industry
|
| Bayer Healthcare,
Bioogical Products Division
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Goldman, Mark
|
|
|
|
|
| EC5
|
| 05/02/2005
|
| 04/12/2005
|
| Private Industry
|
| Genentech
|
|
|
|
|
|
|
| pdf
|
| No attachment received
|
|
|
| Signature:
|
| Tallin, Michelle
|
|
|
|
|
| NEC1
|
|
|
| 05/10/2005
|
| FDA
|
| FDA
|
| 05/11/2005
|
| 24819-24819
|
| 06/11/2005
|
| pdf
|
|
|
|
|
| Signature:
|
| SHUREN, JEFFREY
|
|
|
|
|
| C5
|
| 06/08/2005
|
| 06/08/2005
|
| Private Industry
|
| GlaxoSmithKline
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
|
| Signature:
|
| Mary Faye S. Whisler, Ph. D.
|
|
|
| EC6
|
| 06/17/2005
|
| 06/08/2005
|
| Drug Industry
|
| Teva Pharmaceutical
Industries Ltd.
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
|
| Signature:
|
| Rotem, Nava
|
|
|
|
|
| EC7
|
| 06/17/2005
|
| 06/09/2005
|
| Drug Industry
|
| Teva Pharmaceutical
Industries Ltd.
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Rotem, Nava
|
|
|
|
|
| EC8
|
| 06/17/2005
|
| 06/10/2005
|
| Drug Industry
|
| Boehringer Ingelheim
Pharmaceuticals, Inc.
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Watson, Patricia
|
|
|
|
|
| EC9
|
| 06/17/2005
|
| 06/10/2005
|
| Drug Industry
|
| Generic Pharmaceutical
Association
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Johnston, Gordon
|
|
|
|
|
| EMC1
|
| 06/10/2005
|
| 06/10/2005
|
| Association
|
| PDA
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Lance K Hoboy
|
|
|
|
|
| C6
|
| 06/13/2005
|
| 06/10/2005
|
| Drug Industry
|
| Boehringer Ingelheim
Pharmaceuticals Inc
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Patricia Watson
| |
|
|
|
|
|
| EMC2
|
| 06/16/2005
|
| 06/15/2005
|
| Private Industry
|
| Amgen Inc
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Jenny Peters
| |
Top
| Up
Page last updated
July 13, 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 |
