Draft Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed

Docket ID: FDA-2012-D-0847
Agency: Food and Drug Administration (FDA)
Parent Agency: Department of Health and Human Services (HHS)
Docket Details open glossary dialog  
Related RINs: None
Related Dockets: None
Keyword(s): IND/IDE , Adequacy of Research Sites, Reviewing the Qualifications of Investigators, IRB Responsibilities , Draft Guidance , cder
Type: Nonrulemaking
Center: CDER
Docket Item Code: D

Primary Documents

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Comment Period Closed
Jan 22, 2013 11:59 PM ET
Posted: 11/20/2012
ID: FDA-2012-D-0847-0001
Comment Period Closed
Posted: 08/27/2013
ID: FDA-2012-D-0847-0014

Supporting Documents

No documents available.


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Comments Received*
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