Draft Guidance for Industry and Investigators: Safety Reporting Requirements for Investigational New Drug Applications andBioavailability/Bioequivalence Studies; Availability
Document ID: FDA-2010-D-0482-0001
Comments
Total: 23
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George C Phillips - Comment
Posted : 11/19/2010 ID :FDA-2010-D-0482-0002 Agency : FDA -
Dec 28,2010 11:59 PM ET
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Gilead Sciences, Inc. - Comment
Posted : 11/29/2010 ID :FDA-2010-D-0482-0003 Agency : FDA -
Dec 28,2010 11:59 PM ET
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Baxter Healthcare Corporation - Comment
Posted : 12/17/2010 ID :FDA-2010-D-0482-0004 Agency : FDA -
Dec 28,2010 11:59 PM ET
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PharmaNet - Comment
Posted : 12/21/2010 ID :FDA-2010-D-0482-0005 Agency : FDA -
Dec 28,2010 11:59 PM ET
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AstraZeneca - Comment
Posted : 12/21/2010 ID :FDA-2010-D-0482-0006 Agency : FDA -
Dec 28,2010 11:59 PM ET
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Association of Clinical Research Professionals - Comment
Posted : 12/21/2010 ID :FDA-2010-D-0482-0007 Agency : FDA -
Dec 28,2010 11:59 PM ET
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Merck & Co, Inc. - Comment
Posted : 12/21/2010 ID :FDA-2010-D-0482-0008 Agency : FDA -
Dec 28,2010 11:59 PM ET
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Bob Bader - Comment
Posted : 12/21/2010 ID :FDA-2010-D-0482-0009 Agency : FDA -
Dec 28,2010 11:59 PM ET
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Novo Nordisk Inc. - Comment
Posted : 12/21/2010 ID :FDA-2010-D-0482-0010 Agency : FDA -
Dec 28,2010 11:59 PM ET
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Novartis Pharmaceuticals - Comment
Posted : 12/21/2010 ID :FDA-2010-D-0482-0011 Agency : FDA -
Dec 28,2010 11:59 PM ET
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Amgen, Inc. - Comment
Posted : 12/23/2010 ID :FDA-2010-D-0482-0012 Agency : FDA -
Dec 28,2010 11:59 PM ET
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Consortium of Independent Review Boards (CIRB) - Comment
Posted : 12/27/2010 ID :FDA-2010-D-0482-0013 Agency : FDA -
Dec 28,2010 11:59 PM ET
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Johnson & Johnson Pharmaceutical Research & Development - Comment
Posted : 12/27/2010 ID :FDA-2010-D-0482-0014 Agency : FDA -
Dec 28,2010 11:59 PM ET
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Cancer Therapy Evaluation Program, DCTD, NCI - Comment
Posted : 12/27/2010 ID :FDA-2010-D-0482-0015 Agency : FDA -
Dec 28,2010 11:59 PM ET
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Bausch+Lomb - Comment
Posted : 12/28/2010 ID :FDA-2010-D-0482-0016 Agency : FDA -
Dec 28,2010 11:59 PM ET
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Abbott - Comment
Posted : 12/28/2010 ID :FDA-2010-D-0482-0017 Agency : FDA -
Dec 28,2010 11:59 PM ET
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Biotechnology Industry Organization (BIO) - Comment
Posted : 12/28/2010 ID :FDA-2010-D-0482-0018 Agency : FDA -
Dec 28,2010 11:59 PM ET
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Judith Mae Kramer - Comment
Posted : 12/29/2010 ID :FDA-2010-D-0482-0019 Agency : FDA -
Dec 28,2010 11:59 PM ET
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Elan Pharmaceuticals, Inc. - Comment
Posted : 01/21/2011 ID :FDA-2010-D-0482-0021 Agency : FDA -
Dec 28,2010 11:59 PM ET
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Pharmaceutical Research and Manufacturers of America - Comment
Posted : 01/21/2011 ID :FDA-2010-D-0482-0022 Agency : FDA -
Dec 28,2010 11:59 PM ET
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Johnson & Johnson Pharmaceutical Research & Development - Comment
Posted : 01/26/2011 ID :FDA-2010-D-0482-0023 Agency : FDA -
Dec 28,2010 11:59 PM ET
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Pharmaceutical Research and Manufacturers of America (PhRMA) - Comment
Posted : 01/26/2011 ID :FDA-2010-D-0482-0024 Agency : FDA -
Dec 28,2010 11:59 PM ET
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Pharmaceutical Research and Manufacturers of America (PhRMA) - Comment
Posted : 05/17/2011 ID :FDA-2010-D-0482-0028 Agency : FDA -
Dec 28,2010 11:59 PM ET