Up
2005D-0047:
GUIDANCE FOR INDUSTRY: CONSIDERATIONS FOR PLASMID DNA VACCINES FOR
INFECTIOUS DISEASE INDICATIONS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Document #
|
| Received Date
|
| Filed
Date
|
| Submitter Code
|
| Submitter
|
| FR
Date
|
| FR
Page
|
| Comment Date
|
| Files
|
| Remarks
|
|
|
|
|
| GDL1
|
| 03/01/2005
|
| 03/01/2005
|
| Federal
Government
|
| GUIDANCE
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| NAD1
|
|
|
| 02/17/2005
|
| FDA
|
| FDA
|
| 02/18/2005
|
| 8378-8379
|
| 05/19/2005
|
| pdf
|
|
|
|
| Signature:
|
| SHUREN, JEFFREY
|
|
|
| BKG1
|
| 02/18/2005
|
| 02/18/2005
|
| Federal Government
|
| Background Information
|
|
|
|
|
|
|
| Table
of Contents
|
|
|
|
|
|
| Signature:
|
| Background Information
|
|
|
|
|
|
| C1
|
| 05/19/2005
|
| 05/18/2005
|
| Drug Industry
|
| Wyeth Pharmaceuticals,
Inc.
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Susan J. Sciotto-Brown and Jack
D. L
|
|
|
| C2
|
| 05/19/2005
|
| 05/16/2005
|
| Consumer Group
|
| AIDS Vaccine Advocacy
Coalition (AVAC)
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Mitchell Warren and Robert Reinhard
|
|
|
| EMC1
|
| 05/14/2005
|
| 05/14/2005
|
| Association
|
| AIDS Vaccine Advocacy
Coalition (AVAC)
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Mitchell Warren and Robert Reinhard
|
|
|
| EMC2
|
| 05/19/2005
|
| 05/19/2005
|
| Federal Government
|
| National Institutes
of Health (NIH)
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
| Signature:
|
| Amy P. Patterson, M.D.
|
|
|
|
|
|
| EMC3
|
| 05/19/2005
|
| 05/19/2005
|
| Drug Industry
|
| Merck & Co., Inc.
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Taryn Rogalski-Salter, PhD
|
|
|
| C3
|
| 05/20/2005
|
| 05/19/2005
|
| Private Industry
|
| Vical Incorporated
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| William H. Cover, PhD
|
|
|
| EC1
|
| 05/26/2005
|
| 05/18/2005
|
| Drug Industry
|
| PowderMed Ltd.
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Gannaway, David
|
|
|
| EC2
|
| 05/26/2005
|
| 05/19/2005
|
| Drug Industry
|
| Vical Incorporated
|
|
|
|
|
|
|
| Attachments: 1,
2
|
|
|
|
| Signature:
|
| Cover, William
|
|
|
| C4
|
| 05/25/2005
|
| 05/24/2005
|
| Private Industry
|
| GlaxoSmithKline
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Mary Faye S Whisler PhD
|
|
|
| C5
|
| 06/13/2005
|
| 06/13/2005
|
| Private Industry
|
| Vaccines Research
Advocate
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Jesse Creel
| |
|
| C6
|
| 09/14/2006
|
| 09/11/2006
|
| Drug Industry
|
| Scarab Genomics,
LLC
|
|
|
|
|
|
|
| pdf,
Copyrighted Material
|
|
|
|
| Signature:
|
| Frederick Blattner, PhD
|
|
|
| C7
|
| 10/11/2006
|
| 10/06/2006
|
| Private
Industry
|
| Scarab Genomics
LLC
|
|
|
|
|
|
|
| pdf,
Copyrighted Material
|
|
|
|
| Signature:
|
| John Campbell PhD for Frederick
Blat
|
|
|
| REF1
|
| 10/26/2007
|
| 10/26/2007
|
| Federal
Government
|
| Reference
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Reference
|
|
|
|
|
| GDL2
|
| 10/26/2007
|
| 10/26/2007
|
| Federal
Government
|
| Guidance for
Industry
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Guidance for Industry
|
|
|
|
|
| NAD2
|
|
|
| 10/26/2007
|
| FDA
|
| FDA
|
| 10/29/2007
|
| 61172-61172
|
|
|
| [TXT] [PDF]
|
|
|
|
| Signature:
|
| SHUREN, JEFFREY
| |
|
|
|
| |
Top
| Up
Page last updated
November 2, 2007
kk![horizonal rule](https://webarchive.library.unt.edu/eot2008/20081026055504im_/http://www.fda.gov/graphics/blkpixel.gif)
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 |