| Up
2004D-0484:
GUIDANCE FOR INDUSTRY ON THE ROLE OF HIV DRUG RESISTANCE TESTING
IN ANTIRETROVIRAL DRUG DEVELOPMENT
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Document #
|
| Received Date
|
| Filed
Date
|
| Submitter Code
|
| Submitter
|
| FR
Date
|
| FR
Page
|
| Comment Date
|
| Volume
|
| Remarks
|
|
|
|
|
|
|
| GDL1
|
| 11/26/2004
|
| 11/26/2004
|
| Animal
Feed Industry
|
| Guideline
|
|
|
|
|
|
|
| pdf,
doc
|
|
|
|
|
|
| Signature:
|
| Guideline
|
|
|
|
|
|
|
|
| NAD1
|
|
|
| 11/26/2004
|
| FDA
|
| FDA
|
| 11/29/2004
|
| 69374-69375
|
| 02/28/2005
|
| pdf
|
|
|
|
|
| Signature:
|
| Jeffrey Shuren
|
|
|
|
|
| C1
|
| 02/16/2005
|
| 02/15/2005
|
| Drug Industry
|
| Pfizer,
Inc.
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Jennifer Hammond,
PhD
|
|
|
|
|
| EC1
|
| 02/26/2005
|
| 02/25/2005
|
| Drug Industry
|
| GlaxoSmithKline
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Watts, Ph.D., Susan
|
|
|
|
|
| EC2
|
| 02/26/2005
|
| 02/25/2005
|
| Academia
|
| Stanford
University
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
|
| Signature:
|
| Shafer, Robert
|
|
|
| EC3
|
| 02/26/2005
|
| 02/25/2005
|
| Device Industry
|
| Bayer Diagnostics
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
|
| Signature:
|
| Morgan, Gillian
|
|
|
|
|
| EC4
|
| 03/01/2005
|
| 02/28/2005
|
| Drug Association
|
| Pharm Res
|
|
|
|
|
|
|
| htm
|
|
|
|
|
| Signature:
|
| Goldhammer, Alan
|
|
|
|
|
| C2
|
| 02/24/2005
|
| 02/23/2005
|
| Drug Industry
|
| ViroLogic
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Shannon L. Utter
|
|
|
|
|
| C3
|
| 02/28/2005
|
| 02/25/2005
|
| Drug Industry
|
| VircoLab
Inc.
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Lee Bacheler, PhD
|
|
|
|
|
| C4
|
| 03/02/2005
|
| 02/28/2005
|
| Drug Industry
|
| Bristol-Myers
Squibb Company (BMS)
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Joseph Lamedola, PhD
|
|
|
|
|
| C5
|
| 02/28/2005
|
| 02/25/2005
|
| Drug Industry
|
| Gilead Sciences,
Inc. (Gilead)
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Christophe Beraud,
PhD
| |
Top
| Up
Page last updated
March 11, 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 |
