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2006D-0331:
Guidance for Institutional Review Boards, Clinical Investigators,
and Sponsors; Exception from Informed Consent Requirements for Emergency
Research
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| Document #
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| Received Date
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| Filed
Date
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| Submitter Code
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| Submitter
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| FR
Date
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| FR
Page
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| Comment Date
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| Files
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| Remarks
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| NAD1
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| 08/25/2006
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| FDA
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| FDA
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| 08/29/2006
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| 51198-51199
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| 10/30/2006
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| pdf
htm
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| Signature:
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| Jeffrey Shuren
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| GDL1
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| 08/29/2006
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| 08/29/2006
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| Federal Government
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| Guidance
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| pdf
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| NHC1
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| 08/25/2006
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| FDA
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| FDA
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| 08/29/2006
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| 51143-51146
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| 11/27/2006
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| pdf
htm
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| Hearing on 10/11/06
Presentation by 9/20/06
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| Signature:
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| Jeffrey Shuren
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| EMC1
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| 08/29/2006
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| 08/29/2006
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| Individual Consumer
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| B. Sachau
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| EC1
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| 09/05/2006
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| 09/01/2006
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| Individual Consumer
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| Mr. Darryl Wellinghoff
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| htm
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| EC2
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| 09/11/2006
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| 09/06/2006
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| Individual Consumer
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| Ms. Debra Jo Endres-Ard
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| htm
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| EC3
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| 09/11/2006
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| 09/07/2006
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| Other Organization
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| La Cesta Consultants, LLC
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