| Up
| Back | 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
|
|
|
|
|
|
|
| EC25
|
| 05/02/2005
|
| 04/20/2005
|
| Health Professional
|
| Dr. Jim Monolakis
|
|
|
|
|
|
|
| htm
|
|
|
|
|
| Signature:
|
| Monolakis, Jim
|
|
|
|
|
| EC26
|
| 05/02/2005
|
| 04/20/2005
|
| Academia
|
| University of Michigan
|
|
|
|
|
|
|
| htm
|
|
|
|
|
| Signature:
|
| Nowack, Judith
|
|
|
|
|
| EC27
|
| 05/02/2005
|
| 04/21/2005
|
| Academia
|
| Baylor College of
Medicine
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Berg, Stacey
|
|
|
|
|
| EC28
|
| 05/02/2005
|
| 04/21/2005
|
| Other Organization
|
| Consortium of Independent
Review Boards
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Freeman, John
|
|
|
|
|
| EC29
|
| 05/02/2005
|
| 04/21/2005
|
| Device Association
|
| AdvaMed
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
|
| Signature:
|
| Federici, Tara
|
|
|
| EC30
|
| 05/02/2005
|
| 04/21/2005
|
| Academia
|
| Stanford University
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
|
| Signature:
|
| McClelland, Kathy
|
|
|
|
|
| EC31
|
| 05/02/2005
|
| 04/21/2005
|
| Academia
|
| U.T. M.D. Anderson
Cancer Center
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Shah, Mira
|
|
|
|
|
| EC32
|
| 05/02/2005
|
| 04/21/2005
|
| Academia
|
| Council on Governmental
Relations
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Phillips, Katharina
|
|
|
|
|
| EC33
|
| 05/02/2005
|
| 04/21/2005
|
| Academia
|
| SUNY Human Subjects
Forum
|
|
|
|
|
|
|
| htm
|
|
|
|
|
| Signature:
|
| Matuk, Judy
|
|
|
|
|
| EC34
|
| 05/02/2005
|
| 04/21/2005
|
| Drug Association
|
| Pharm Res
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Goldhammer, Alan
|
|
|
|
|
| EC35
|
| 05/02/2005
|
| 04/21/2005
|
| Private Industry
|
| Chesapeake Research
Review, Inc.
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Seidman, Madeleine
|
|
|
|
|
| EC36
|
| 05/02/2005
|
| 04/21/2005
|
| Private Industry
|
| Quorum Review, Inc.
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Mynhier, Mark
|
|
|
|
|
| EC37
|
| 05/02/2005
|
| 04/22/2005
|
| Drug Industry
|
| Pfizer Inc
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
|
| Signature:
|
| Gregory, W.
|
|
|
| EC38
|
| 05/02/2005
|
| 04/22/2005
|
| Drug Industry
|
| Pfizer Inc
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
|
| Signature:
|
| Gregory, W.
|
|
|
|
|
| EMC6
|
| 04/15/2005
|
| 04/15/2005
|
| Academia
|
| Johns Hopkins
Bloomberg School of Public Health
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
|
|
| Signature:
|
| Nathaniel F. Pierce
|
|
|
|
|
| EMC7
|
| 04/18/2005
|
| 04/18/2005
|
| Health Professional
|
| D. Wynes, PhD
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| EMC8
|
| 04/20/2005
|
| 04/20/2005
|
| Private Industry
|
| Cook Group, Inc. (Cook)
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Merry Lee Bain
|
|
|
|
|
| EMC9
|
| 04/20/2005
|
| 04/20/2005
|
| Individual Consumer
|
| R. Reinhard
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| EMC10
|
| 04/21/2005
|
| 04/21/2005
|
| Consumer Group
|
| Consortium
of Independent Review Boards (CIRB)
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
|
|
|
|
|
| Signature:
|
| John S. Freeman, Esq
| |
Top | Up
| Back | Most Recent
Page last updated
June 20, 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 |