Draft Guidance for Industry on Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products; Extension of Comment Period
Document ID: FDA-2012-D-1145-0005
Comments
Total: 24
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Robert A. Beckman - Comment
Posted : 03/19/2013 ID ：FDA-2012-D-1145-0006 Agency : FDA -
Mar 18,2013 11:59 PM ET
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James F. Lancaster - Comment
Posted : 03/19/2013 ID ：FDA-2012-D-1145-0007 Agency : FDA -
Mar 18,2013 11:59 PM ET
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Novartis - Comment
Posted : 03/19/2013 ID ：FDA-2012-D-1145-0008 Agency : FDA -
Mar 18,2013 11:59 PM ET
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Novo Nordisk Inc. - Comment
Posted : 03/19/2013 ID ：FDA-2012-D-1145-0009 Agency : FDA -
Mar 18,2013 11:59 PM ET
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James P. McCarthy (Daiichi Sankyo Inc.) - Comment
Posted : 03/19/2013 ID ：FDA-2012-D-1145-0010 Agency : FDA -
Mar 18,2013 11:59 PM ET
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Roche Diagnostics - Comment
Posted : 03/19/2013 ID ：FDA-2012-D-1145-0011 Agency : FDA -
Mar 18,2013 11:59 PM ET
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Lupus Foundation of America - Comment
Posted : 03/19/2013 ID ：FDA-2012-D-1145-0012 Agency : FDA -
Mar 18,2013 11:59 PM ET
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EFSPI/PSI - Comment
Posted : 03/19/2013 ID ：FDA-2012-D-1145-0013 Agency : FDA -
Mar 18,2013 11:59 PM ET
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Pharmaceutical Research and Manufacturers of America (PhRMA) - Comment
Posted : 03/19/2013 ID ：FDA-2012-D-1145-0014 Agency : FDA -
Mar 18,2013 11:59 PM ET
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Mayumi Nagashima (SHIONOGI & CO., LTD.) - Comment
Posted : 03/19/2013 ID ：FDA-2012-D-1145-0015 Agency : FDA -
Mar 18,2013 11:59 PM ET
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Boehringer Ingelheim Pharmaceuticals, Inc - Comment
Posted : 03/19/2013 ID ：FDA-2012-D-1145-0016 Agency : FDA -
Mar 18,2013 11:59 PM ET
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Merck & Co, Inc. - Comment
Posted : 03/19/2013 ID ：FDA-2012-D-1145-0017 Agency : FDA -
Mar 18,2013 11:59 PM ET
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Roche Genentech - Comment
Posted : 03/19/2013 ID ：FDA-2012-D-1145-0018 Agency : FDA -
Mar 18,2013 11:59 PM ET
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AbbVie - Comment
Posted : 03/19/2013 ID ：FDA-2012-D-1145-0019 Agency : FDA -
Mar 18,2013 11:59 PM ET
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Eli Lilly and Company - Comment
Posted : 03/19/2013 ID ：FDA-2012-D-1145-0020 Agency : FDA -
Mar 18,2013 11:59 PM ET
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Amgen Inc. - Comment
Posted : 03/19/2013 ID ：FDA-2012-D-1145-0021 Agency : FDA -
Mar 18,2013 11:59 PM ET
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Teva Pharmaceuticals - Comment
Posted : 03/19/2013 ID ：FDA-2012-D-1145-0022 Agency : FDA -
Mar 18,2013 11:59 PM ET
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Sanofi - Comment
Posted : 03/19/2013 ID ：FDA-2012-D-1145-0023 Agency : FDA -
Mar 18,2013 11:59 PM ET
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Eloise Kaizar - Comment
Posted : 03/19/2013 ID ：FDA-2012-D-1145-0024 Agency : FDA -
Mar 18,2013 11:59 PM ET
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Pfizer Inc - Comment
Posted : 03/19/2013 ID ：FDA-2012-D-1145-0025 Agency : FDA -
Mar 18,2013 11:59 PM ET
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Advanced Medical Technology Association (AdvaMed) - Comment
Posted : 03/19/2013 ID ：FDA-2012-D-1145-0026 Agency : FDA -
Mar 18,2013 11:59 PM ET
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Living Well Black Inc (LWB) - Comment
Posted : 03/19/2013 ID ：FDA-2012-D-1145-0027 Agency : FDA -
Mar 18,2013 11:59 PM ET
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Adaptive Plus, LLC - Comment
Posted : 03/19/2013 ID ：FDA-2012-D-1145-0028 Agency : FDA -
Mar 18,2013 11:59 PM ET
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American Association for Cancer Research (AACR) - Comment
Posted : 03/19/2013 ID ：FDA-2012-D-1145-0029 Agency : FDA -
Mar 18,2013 11:59 PM ET