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2006D-0331: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research

Document # Received Date Filed Date Submitter Code Submitter FR Date FR Page Comment Date Files Remarks
NAD1   08/25/2006 FDA FDA 08/29/2006 51198-51199 10/30/2006 pdf
htm
 
Signature: Jeffrey Shuren
GDL1 08/29/2006 08/29/2006 Federal Government
Guidance       pdf  
NHC1   08/25/2006 FDA FDA 08/29/2006 51143-51146 11/27/2006 pdf
htm
Hearing on 10/11/06
Presentation by 9/20/06

Signature: Jeffrey Shuren
EMC1 08/29/2006 08/29/2006 Individual Consumer B. Sachau        
EC1 09/05/2006 09/01/2006 Individual Consumer Mr. Darryl Wellinghoff       htm  
EC2 09/11/2006 09/06/2006 Individual Consumer Ms. Debra Jo Endres-Ard       htm  
EC3 09/11/2006 09/07/2006 Other Organization La Cesta Consultants, LLC