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Home » Rulemaking » Draft Guidance for IRBs, Clinical Investigators, and Sponsors; Availability: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research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

Draft Guidance for IRBs, Clinical Investigators, and Sponsors; Availability: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research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

Document ID: FDA-2012-D-0847-0001
Document Type: Notice
Agency: Food And Drug Administration
Topics: No Topics associated with this document
Federal Register Number: 2012-28149
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Details Information

Document Subtype: Notice of Availability
Received Date: November 20 2012, at 12:00 AM Eastern Standard Time
Start-End Page: 69631 - 69632
Page Count: 2
Comment Start Date: November 20 2012, at 12:00 AM Eastern Standard Time
Comment Due Date: January 22 2013, at 11:59 PM Eastern Standard Time

Comments

    View All
Total: 9
Emine A. Kanik - Comment
Posted: 12/28/2012     ID: FDA-2012-D-0847-0003

Jan 22,2013 11:59 PM ET
Consortium of Independent Review Boards (CIRB) - Comment
Posted: 01/23/2013     ID: FDA-2012-D-0847-0007

Jan 22,2013 11:59 PM ET
Walter Reed Army Institute of Research - Comment
Posted: 01/23/2013     ID: FDA-2012-D-0847-0005

Jan 22,2013 11:59 PM ET
AstraZeneca - Comment
Posted: 01/23/2013     ID: FDA-2012-D-0847-0004

Jan 22,2013 11:59 PM ET
Society for Clinical Research Sites (SCRS) - Comment
Posted: 01/23/2013     ID: FDA-2012-D-0847-0006

Jan 22,2013 11:59 PM ET

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