Up
2005D-0057:
REVIEWER GUIDANCE ON CONDUCTING A CLINICAL SAFETY REVIEW OF A NEW
PRODUCT APPLICATION AND PREPARING A REPORT ON THE REVIEW; AVAILABILITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Document #
|
| Received Date
|
| Filed
Date
|
| Submitter Code
|
| Submitter
|
| FR
Date
|
| FR
Page
|
| Comment Date
|
| Volume
|
| Remarks
|
|
|
|
|
| GDL1
|
| 02/18/2005
|
| 02/18/2005
|
| Federal
Government
|
| GUIDANCE
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| GUIDANCE
|
|
|
|
|
| NAD1
|
|
|
| 02/17/2005
|
| FDA
|
| FDA
|
| 02/18/2005
|
| 8381-8381
|
| 02/20/2006
|
| pdf
|
|
|
|
| Signature:
|
| SHUREN, JEFFREY
| |
Top
| Up
Page last updated
March 15, 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 |