| Up | Back | Next | Most Recent
2005N-0038:
REPORTING OF ADVERSE EVENTS TO INSTITUTIONAL REVIEW BOARDS; PUBLIC
HEARING
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Document #
|
| Received Date
|
| Filed
Date
|
| Submitter Code
|
| Submitter
|
| FR
Date
|
| FR
Page
|
| Comment Date
|
| Files
|
| Remarks
|
|
|
|
|
|
|
| EAPE19
|
| 02/10/2005
|
| 02/10/2005
|
| Private
Industry
|
| McIntosh,
Charles
|
|
|
|
|
|
|
|
|
|
|
|
|
| Signature:
|
| McIntosh, Charles
|
|
|
|
|
| EAPE20
|
| 02/10/2005
|
| 02/10/2005
|
| Federal
Government
|
| Makhene,
Mamodikoe
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Signature:
|
| Makhene, Mamodikoe
|
|
|
|
|
|
|
|
| EAPE21
|
| 02/10/2005
|
| 02/10/2005
|
| Federal
Government
|
| Melvin,
Marsha
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Signature:
|
| Melvin, Marsha
|
|
|
|
|
|
|
|
| EAPE22
|
| 02/10/2005
|
| 02/10/2005
|
| Academia
|
| Bankowski,
Susan
|
|
|
|
|
|
|
|
|
|
|
|
|
| Signature:
|
| Bankowski, Susan
|
|
|
|
|
| EAPE23
|
| 02/10/2005
|
| 02/10/2005
|
| Federal
Government
|
| Woltz, Patricia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Signature:
|
| Woltz, Patricia
|
|
|
|
|
| EAPE24
|
| 02/10/2005
|
| 02/10/2005
|
| Academia
|
| Bishop,
Laura
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Signature:
|
| Bishop, Laura
|
|
|
|
|
| EAPE25
|
| 02/10/2005
|
| 02/10/2005
|
| Federal
Government
|
| Fracisco,
Susan
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Signature:
|
| Fracisco, Susan
|
|
|
|
|
|
|
|
| EAPE26
|
| 02/10/2005
|
| 02/10/2005
|
| Federal
Government
|
| Gaffey,
Claudia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Signature:
|
| Gaffey, Claudia
|
|
|
|
|
|
|
|
| EAPE27
|
| 02/10/2005
|
| 02/10/2005
|
| Federal
Government
|
| Cates, Lynn
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Signature:
|
| Cates, Lynn
|
|
|
|
|
|
|
|
| EAPE28
|
| 02/10/2005
|
| 02/10/2005
|
| Academia
|
| West, Dennis
|
|
|
|
|
|
|
|
|
|
|
|
|
| Signature:
|
| West, Dennis
|
|
|
|
|
| APE1
|
| 02/09/2005
|
| 02/09/2005
|
| Association
|
| National
Council on Ethics in Human Research
|
|
|
|
|
|
|
|
|
|
|
|
|
| Signature:
|
| Chloe Bouza
|
|
|
|
|
| EAPE29
|
| 02/11/2005
|
| 02/10/2005
|
| Federal
Government
|
| Bicknell,
Eleanor
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Signature:
|
| Bicknell, Eleanor
|
|
|
|
|
|
|
|
| EAPE30
|
| 02/11/2005
|
| 02/10/2005
|
| Federal
Government
|
| Stith-Coleman,
Irene
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Signature:
|
| Stith-Coleman, Irene
|
|
|
|
|
| EAPE31
|
| 02/11/2005
|
| 02/10/2005
|
| Federal
Government
|
| Kaneshiro,
Julie
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Signature:
|
| Kaneshiro, Julie
|
|
|
|
|
| EAPE32
|
| 02/11/2005
|
| 02/10/2005
|
| Federal
Government
|
| Hazra, Rohan
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Signature:
|
| Hazra, Rohan
|
|
|
|
|
|
|
|
| EAPE33
|
| 02/11/2005
|
| 02/10/2005
|
| Academia
|
| Pettit,
Joan
|
|
|
|
|
|
|
|
|
|
|
|
|
| Signature:
|
| Pettit, Joan
|
|
|
|
|
| EAPE34
|
| 02/11/2005
|
| 02/10/2005
|
| Federal
Government
|
| Yimam, Solomon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Signature:
|
| Yimam, Solomon
|
|
|
|
|
|
|
|
| EAPE35
|
| 02/11/2005
|
| 02/10/2005
|
| Federal
Government
|
| Lee, Bonnie
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Signature:
|
| Lee, Bonnie
|
|
|
|
|
|
|
|
| EAPE36
|
| 02/11/2005
|
| 02/10/2005
|
| Federal
Government
|
| McDougall,
Skye
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Signature:
|
| McDougall, Skye
|
|
|
| |
Top
| Up | Back | Next | Most Recent
Page last updated
March 31, 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 |