Up
| Next || Most Recent
2005D-0062:
Draft Guidance FDAs Drug Watch for Emerging Drug Safety
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Document #
|
| Received Date
|
| Filed
Date
|
| Submitter Code
|
| Submitter
|
| FR
Date
|
| FR
Page
|
| Comment Date
|
| Files
|
| Remarks
|
|
|
|
|
| GDL1
|
| 05/10/2005
|
| 05/09/2005
|
| Federal
Government
|
| Guidance
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Guidance
|
|
|
|
|
| NAD1
|
|
|
| 05/09/2005
|
| FDA
|
| FDA
|
| 05/10/2005
|
| 24606-24607
|
| 08/08/2005
|
| pdf
|
|
|
|
| Signature:
|
| Jeffrey Shuren
|
|
|
| EC1
|
| 05/26/2005
|
| 05/11/2005
|
| Media
|
| Pharma Marketing News
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Mack, John
|
|
|
| EMC1
|
| 05/22/2005
|
| 05/22/2005
|
| Individual Consumer
|
| B. Sachau
|
|
|
|
|
|
|
|
|
|
|
|
|
| EC2
|
| 06/17/2005
|
| 06/13/2005
|
| Health Care Association
|
| National Organization
for Rare Disorders (NORD)
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
| Signature:
|
| Meyers, Abbey
|
|
|
| EC3
|
| 06/17/2005
|
| 06/13/2005
|
| Health Care
Association
|
| National Organization
for Rare Disorders (NORD)
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
|
| Signature:
|
| Meyers, Abbey
|
|
|
| EC4
|
| 06/17/2005
|
| 06/13/2005
|
| Health Care
Association
|
| National Organization
for Rare Disorders (NORD)
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Meyers, Abbey
|
|
|
|
|
| C1
|
| 06/17/2005
|
| 06/14/2005
|
| Association
|
| National Organization
for Rare Disorders Inc
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Abbey S Meyers
|
|
|
| C2
|
| 06/17/2005
|
| 06/15/2005
|
| Drug Industry
|
| Ovation Pharmaceuticals
Inc
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Kathryn B Patterson
| |
|
| C3
|
| 07/25/2005
|
| 07/21/2005
|
| Drug Industry
|
| Wyeth Pharmaceuticals
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Roy J. Baranello, Jr.
|
|
|
| C4
|
| 08/01/2005
|
| 07/29/2005
|
| Association
|
| Society for Women's
Health Research
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Phyllis Greenberger, Martha
Nolan
|
|
|
| C5
|
| 08/02/2005
|
| 08/01/2005
|
| Drug Industry
|
| AstraZeneca LP
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Anthony F Rogers
|
|
|
| C6
|
| 08/05/2005
|
| 08/04/2005
|
| Drug Industry
|
| Novartis Pharmaceuticals
Corporation
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Judith M. Sills, PharmD
|
|
|
| C7
|
| 08/08/2005
|
| 08/08/2005
|
| Drug Industry
|
| GlaxoSmithKline (GSK)
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Edward N. Pattishall,MD,MPH
|
|
|
| C8
|
| 08/08/2005
|
| 08/05/2005
|
| Drug Industry
|
| Eli Lilly and Company
(Lilly)
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Timothy R. Franson, M.D.
|
|
|
| C9
|
| 08/08/2005
|
| 08/08/2005
|
| Drug Industry
|
| National
Council on Patient Information and Education (NCPIE)
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
| Signature:
|
| William Ray Bullman
|
|
|
| C10
|
| 08/08/2005
|
| 08/08/2005
|
| Drug Industry
|
| Abbott Laboratories
(Abbott)
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Douglas L. Sporn
|
|
|
| C11
|
| 08/08/2005
|
| 08/05/2005
|
| Drug Industry
|
| Genentech
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Robert L. Garnick, PhD
|
|
|
| C12
|
| 08/08/2005
|
| 08/08/2005
|
| Association
|
| American Society of
Clinical Oncology (ASCO)
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Sandra J. Horning, MD
| |
Top | Up
| Next || Most Recent
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
|