Draft Guidance for IRBs, Clinical Investigators, and Sponsors; Availability: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research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
Comments
Total: 9
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Emine A. Kanik - Comment
Posted : 12/28/2012 ID ：FDA-2012-D-0847-0003 Agency : FDA -
Jan 22,2013 11:59 PM ET
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AstraZeneca - Comment
Posted : 01/23/2013 ID ：FDA-2012-D-0847-0004 Agency : FDA -
Jan 22,2013 11:59 PM ET
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Walter Reed Army Institute of Research - Comment
Posted : 01/23/2013 ID ：FDA-2012-D-0847-0005 Agency : FDA -
Jan 22,2013 11:59 PM ET
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Society for Clinical Research Sites (SCRS) - Comment
Posted : 01/23/2013 ID ：FDA-2012-D-0847-0006 Agency : FDA -
Jan 22,2013 11:59 PM ET
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Consortium of Independent Review Boards (CIRB) - Comment
Posted : 01/23/2013 ID ：FDA-2012-D-0847-0007 Agency : FDA -
Jan 22,2013 11:59 PM ET
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Association of Clinical Research Organizations (ACRO) - Comment
Posted : 01/23/2013 ID ：FDA-2012-D-0847-0008 Agency : FDA -
Jan 22,2013 11:59 PM ET
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Association of Clinical Research Professionals (ACRP) - Comment
Posted : 01/23/2013 ID ：FDA-2012-D-0847-0009 Agency : FDA -
Jan 22,2013 11:59 PM ET
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Advanced Medical Technology Association (AdvaMed) - Comment
Posted : 01/23/2013 ID ：FDA-2012-D-0847-0010 Agency : FDA -
Jan 22,2013 11:59 PM ET
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Teva Pharmaceuticals - Comment
Posted : 02/01/2013 ID ：FDA-2012-D-0847-0012 Agency : FDA -
Jan 22,2013 11:59 PM ET