|
2006D-0017:
Human Subject Protection--Information for Institutional Review Boards,
Clinical Investigators, and Sponsors; Rescission, Reissuance, and
Development of FDA Guidance Documents
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Document #
|
| Received Date
|
| Filed
Date
|
| Submitter Code
|
| Submitter
|
| FR
Date
|
| FR
Page
|
| Comment Date
|
| Files
|
| Remarks
|
|
|
|
|
|
|
| GDL1
|
| 02/02/2006
|
| 02/15/2006
|
| Federal Government
|
| Information Sheet
Guidance For IRBs,Clinical Investigators, and Sponsors
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Information Sheet Guidance For
IRBs
|
|
|
|
|
| GDL2
|
| 02/02/2006
|
| 02/15/2006
|
| Federal Government
|
| FDA Institutional
Review Board Inspections
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
|
| Signature:
|
| Information Sheet Guidance for
IRBs,
|
|
|
|
|
| GDL3
|
| 02/02/2006
|
| 02/15/2006
|
| Federal Government
|
| Waiver of IRB Requirements
for Drug and Biological Products Stuides
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Waiver of IRB Requirements for
Drug
|
|
|
|
|
| GDL4
|
| 02/02/2006
|
| 02/15/2006
|
| Federal Government
|
| Significant Risk and
Nonsignificant Risk Medical Device Studies
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Significant Risk and Nonsignificant
Ris
|
|
|
|
|
| GDL5
|
| 02/02/2006
|
| 02/15/2006
|
| Federal Government
|
| Frequently Asked Questions
About Medical Devices
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
|
| Signature:
|
| Frequently Asked Questions About
M
|
|
|
|
|
| NAD1
|
|
|
| 02/02/2006
|
| FDA
|
| FDA
|
| 02/03/2006
|
| 5861-5862
|
| 04/04/2006
|
| txt
|
|
|
|
|
| Signature:
|
| SHUREN, JEFFREY
|
|
|
|
|
| C1
|
| 04/04/2006
|
| 04/04/2006
|
| Device Association
|
| Advanced Medical Technology
Association (AdvaMed)
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Tara Federici
|
|
|
|
|
| EC1
|
| 05/03/2006
|
| 03/31/2006
|
| Drug Industry
|
| Quintiles, Inc.
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Alm, Amy
|
|
|
|
|
| EC2
|
| 05/03/2006
|
| 04/04/2006
|
| International Industry
|
| BILIM PHARMACEUTICALS
|
|
|
|
|
|
|
| htm
|
|
|
|
|
|
|
| Signature:
|
| YUCEL, EMRE
|
|
Top | Up Page last updated:
January 8, 2007
|
