Draft Guidance for Industry; Availability: Oversight of Clinical Investigations; A Risk-Based Approach to Monitoring
Document ID: FDA-2011-D-0597-0001
Comments
Total: 34
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Jules T Mitchel - Comment
Posted : 09/29/2011 ID ：FDA-2011-D-0597-0003 Agency : FDA -
Nov 28,2011 11:59 PM ET
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Anonymous - Comment
Posted : 09/29/2011 ID ：FDA-2011-D-0597-0004 Agency : FDA -
Nov 28,2011 11:59 PM ET
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Janet Athene Lane - Comment
Posted : 11/14/2011 ID ：FDA-2011-D-0597-0008 Agency : FDA -
Nov 28,2011 11:59 PM ET
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Cheryl Elaine Kelly - Comment
Posted : 11/14/2011 ID ：FDA-2011-D-0597-0011 Agency : FDA -
Nov 28,2011 11:59 PM ET
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Wayne Martin - Comment
Posted : 11/14/2011 ID ：FDA-2011-D-0597-0014 Agency : FDA -
Nov 28,2011 11:59 PM ET
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Bausch+Lomb - Comment
Posted : 12/05/2011 ID ：FDA-2011-D-0597-0016 Agency : FDA -
Nov 28,2011 11:59 PM ET
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Quintiles - Comment
Posted : 12/05/2011 ID ：FDA-2011-D-0597-0017 Agency : FDA -
Nov 28,2011 11:59 PM ET
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Kuros Biosurgery AG - Comment
Posted : 12/05/2011 ID ：FDA-2011-D-0597-0018 Agency : FDA -
Nov 28,2011 11:59 PM ET
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Novo Nordisk Inc. - Comment
Posted : 12/05/2011 ID ：FDA-2011-D-0597-0019 Agency : FDA -
Nov 28,2011 11:59 PM ET
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Sanofi - Comment
Posted : 12/05/2011 ID ：FDA-2011-D-0597-0020 Agency : FDA -
Nov 28,2011 11:59 PM ET
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Society of Quality Assurance (SOA) - Comment
Posted : 12/05/2011 ID ：FDA-2011-D-0597-0021 Agency : FDA -
Nov 28,2011 11:59 PM ET
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American College of Cardiology (ACC) - Comment
Posted : 12/05/2011 ID ：FDA-2011-D-0597-0022 Agency : FDA -
Nov 28,2011 11:59 PM ET
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European CRO Federation (EUCROF) - Comment
Posted : 12/05/2011 ID ：FDA-2011-D-0597-0023 Agency : FDA -
Nov 28,2011 11:59 PM ET
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Oxford University Clinical Trial Service Unit (CTSU - Comment
Posted : 12/05/2011 ID ：FDA-2011-D-0597-0024 Agency : FDA -
Nov 28,2011 11:59 PM ET
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KKS-Network (Network of Coordinating Centres for Clinical Trials) - Comment
Posted : 12/05/2011 ID ：FDA-2011-D-0597-0025 Agency : FDA -
Nov 28,2011 11:59 PM ET
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Pharmaceutical Research and Manufacturers of America (PhRMA) - Comment
Posted : 12/05/2011 ID ：FDA-2011-D-0597-0026 Agency : FDA -
Nov 28,2011 11:59 PM ET
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Advanced Medical Technology Association (AdvaMed) - Comment
Posted : 12/05/2011 ID ：FDA-2011-D-0597-0027 Agency : FDA -
Nov 28,2011 11:59 PM ET
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Merck Sharp & Dohme Corporation, Merck & Co., Inc. (Merck) - Comment
Posted : 12/05/2011 ID ：FDA-2011-D-0597-0028 Agency : FDA -
Nov 28,2011 11:59 PM ET
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SAIC Frederick - Comment
Posted : 12/05/2011 ID ：FDA-2011-D-0597-0029 Agency : FDA -
Nov 28,2011 11:59 PM ET
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Anonymous - Comment
Posted : 12/05/2011 ID ：FDA-2011-D-0597-0030 Agency : FDA -
Nov 28,2011 11:59 PM ET
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Regeneron Pharmaceuticals, Inc. - Comment
Posted : 12/05/2011 ID ：FDA-2011-D-0597-0031 Agency : FDA -
Nov 28,2011 11:59 PM ET
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Johanna Stamates, University of Miami - Comment
Posted : 12/05/2011 ID ：FDA-2011-D-0597-0032 Agency : FDA -
Nov 28,2011 11:59 PM ET
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Novella - Comment
Posted : 12/05/2011 ID ：FDA-2011-D-0597-0033 Agency : FDA -
Nov 28,2011 11:59 PM ET
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Pfizer Inc. - Comment
Posted : 12/05/2011 ID ：FDA-2011-D-0597-0034 Agency : FDA -
Nov 28,2011 11:59 PM ET
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Johnson & Johnson - Comment
Posted : 12/05/2011 ID ：FDA-2011-D-0597-0035 Agency : FDA -
Nov 28,2011 11:59 PM ET
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Biotechnology Industry Organization (BIO) - Comment
Posted : 11/28/2011 ID ：FDA-2011-D-0597-0036 Agency : FDA -
Nov 28,2011 11:59 PM ET
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Novartis Pharmaceuticals Corporation (NPC) - Comment
Posted : 12/05/2011 ID ：FDA-2011-D-0597-0037 Agency : FDA -
Nov 28,2011 11:59 PM ET
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Cook Group, Inc. - Comment
Posted : 12/05/2011 ID ：FDA-2011-D-0597-0038 Agency : FDA -
Nov 28,2011 11:59 PM ET
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Duke Clinical Research Institute (DCRI) - Comment
Posted : 12/05/2011 ID ：FDA-2011-D-0597-0039 Agency : FDA -
Nov 28,2011 11:59 PM ET
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Association of Clinical Research Organizations (ACRO) - Comment
Posted : 12/05/2011 ID ：FDA-2011-D-0597-0040 Agency : FDA -
Nov 28,2011 11:59 PM ET