Up
2006D-0226:
Prescription Drug Marketing Act Pedigree Requirements under 21 CFR
Part 203; Effective Date and Compliance Policy Guide
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Document #
|
| Received Date
|
| Filed
Date
|
| Submitter Code
|
| Submitter
|
| FR
Date
|
| FR
Page
|
| Comment Date
|
| Files
|
| Remarks
|
|
|
|
|
| NAD1
|
|
|
| 06/13/2006
|
| FDA
|
| FDA
|
| 06/14/2006
|
| 34249-34251
|
| 07/14/2006
|
| txt
|
|
|
|
| Signature:
|
| JEFFREY SHUREN
|
|
|
| GDL1
|
| 06/13/2006
|
| 06/13/2006
|
| Federal Government
|
| Guidance
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
| Signature:
|
| Guidance
|
|
|
| C1
|
| 07/11/2006
|
| 07/08/2006
|
| Individual Consumer
|
| D. Lowe
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| EC1
|
| 07/13/2006
|
| 07/12/2006
|
| Drug Industry
|
| Pfizer Inc.
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| McPhillips, Tom
|
|
|
| C2
|
| 07/14/2006
|
| 07/14/2006
|
| Association
|
| National Association
of Chain Drug Stores (NACDS)
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Mary Ann Wagner, R.Ph.
|
|
|
| EC2
|
| 07/17/2006
|
| 07/14/2006
|
| Drug Industry
|
| Talecris Biotherapeutics,
Inc.
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Lamb, Mary Ann
|
|
|
| EC3
|
| 07/17/2006
|
| 07/14/2006
|
| International Organization
|
| Aegate Inc
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
| Signature:
|
| Gill, Andrew
|
|
|
| EC4
|
| 07/17/2006
|
| 07/14/2006
|
| Federal Government
|
| PD-Rx Pharmaceuticals,
Inc.
|
|
|
|
|
|
|
| htm
|
|
|
|
|
|
| Signature:
|
| McCall, Jack
|
|
|
| EC5
|
| 07/17/2006
|
| 07/14/2006
|
| Drug Association
|
| National Association
of Chain Drug Stores
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Darvey, Diane
|
|
|
| EC6
|
| 07/17/2006
|
| 07/14/2006
|
| Drug Association
|
| Healthcare Distribution
Management Association
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Ducca, Anita
|
|
|
| EC7
|
| 07/17/2006
|
| 07/14/2006
|
| Drug Industry
|
| Abbott
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Kaufman, Zena
|
|
|
| EC8
|
| 07/17/2006
|
| 07/14/2006
|
| Health Care Association
|
| American Pharmacists
Association
|
|
|
|
|
|
|
| pdf
Attachment
|
|
|
|
|
|
| Signature:
|
| Gans, John
|
|
|
| EC9
|
| 07/17/2006
|
| 07/14/2006
|
| Private Industry
|
| McKesson Corporation
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Berkey, Ann
|
|
|
| C3
|
| 07/17/2006
|
| 07/14/2006
|
| Drug Industry
|
| Abbott
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Zena Kaufman
| |
|
|
C4 |
|
08/07/2006
|
|
08/01/2006
|
|
Device Industry
|
|
PSS World Medical,
Inc. (PSSI) |
|
|
|
|
|
|
|
pdf |
|
|
|
|
Signature: |
|
David A. Smith |
|
|
|
C5 |
|
09/06/2006
|
|
09/05/2006
|
|
Drug Industry
|
|
STAT Pharmaceuticals
|
|
|
|
|
|
|
|
pdf |
|
|
|
|
Signature: |
|
Gene N Alley |
|
|
|
C6 |
|
09/06/2006
|
|
09/05/2006
|
|
Association
|
|
American Veterinary
Distributors Association AVDA |
|
|
|
|
|
|
|
pdf |
|
|
|
|
Signature: |
|
Jackie King |
|
|
|
C7 |
|
09/12/2006
|
|
09/05/2006
|
|
Individual Consumer
|
|
Pharma Corp.
|
|
|
|
|
|
|
|
pdf |
|
|
|
|
Signature: |
|
Victor A. Arzabe
|
|
|
| C8
|
| 10/19/2006
|
| 10/19/2006
|
| Drug Industry
|
| STAT Pharmaceuticals,
Inc.
|
|
|
|
|
|
|
| pdf
|
| CF 1992N-0297, 1988N-0258
|
|
| Signature:
|
| Gene N. Alley
| |
|
| C9
|
| 10/19/2006
|
| 10/19/2006
|
| Drug Industry
|
| STAT Pharmaceuticals,
Inc.
|
|
|
|
|
|
|
| pdf
|
| CF 1992N-0297, 1988N-0258
|
|
| Signature:
|
| Mark C. Snyder
|
|
|
| GDL3
|
| 11/15/2006
|
| 11/14/2006
|
| Federal Government
|
| Guidance
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
| Signature:
|
| Guidance
|
|
|
| NAD2
|
|
|
| 11/14/2006
|
| FDA
|
| FDA
|
| 11/15/2006
|
| 66448-66450
|
| 11/14/2007
|
| htm
|
| Effective date 12/01/2006
|
|
| Signature:
|
| JEFFREY SHUREN
|
|
|
|
| EC10
|
| 12/08/2006
|
| 12/07/2006
|
| Individual Consumer
|
| Mrs. Mara Fritts
|
|
|
|
|
|
|
| htm
|
|
|
|
|
| EC11
|
| 12/26/2006
|
| 12/24/2006
|
| Individual Consumer
|
| Mrs. Debra Orellana
|
|
|
|
|
|
|
| htm
|
|
|
|
|
| EC12
|
| 12/29/2006
|
| 12/28/2006
|
| Individual Consumer
|
| Ms. Roberta Wynn
|
|
|
|
|
|
|
| htm
|
|
|
|
|
| EC13
|
| 12/29/2006
|
| 12/28/2006
|
| Consumer Group
|
| Life Choices UFS Pregnancy
Resource Center
|
|
|
|
|
|
|
| htm
|
|
|
|
| Signature:
|
| O, Janice
|
|
|
| EC14
|
| 12/29/2006
|
| 12/28/2006
|
| Individual Consumer
|
| Mr. cary brief
|
|
|
|
|
|
|
| htm
|
|
|
|
|
Top | Up
Page last updated
January 18, 2007
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 |