Draft Guidance for Industry: Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes Reportable in Annual Reports; Availability
Document ID: FDA-2010-D-0283-0001
Comments
Total: 27
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Dale S. Carlson - Comment
Posted : 07/13/2010 ID ：FDA-2010-D-0283-0003 Agency : FDA -
Sep 23,2010 11:59 PM ET
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AstraZeneca - Comment
Posted : 10/04/2010 ID ：FDA-2010-D-0283-0004 Agency : FDA -
Sep 23,2010 11:59 PM ET
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Sepracor Inc. - Comment
Posted : 10/04/2010 ID ：FDA-2010-D-0283-0005 Agency : FDA -
Sep 23,2010 11:59 PM ET
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SOCMA Bulk Pharmaceutical Task Force - Comment
Posted : 10/04/2010 ID ：FDA-2010-D-0283-0006 Agency : FDA -
Sep 23,2010 11:59 PM ET
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Abbott - Comment
Posted : 10/04/2010 ID ：FDA-2010-D-0283-0007 Agency : FDA -
Sep 23,2010 11:59 PM ET
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Bausch+Lomb - Comment
Posted : 10/04/2010 ID ：FDA-2010-D-0283-0008 Agency : FDA -
Sep 23,2010 11:59 PM ET
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Anonymous - Comment
Posted : 10/04/2010 ID ：FDA-2010-D-0283-0009 Agency : FDA -
Sep 23,2010 11:59 PM ET
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Baxter Healthcare Corporation - Comment
Posted : 10/04/2010 ID ：FDA-2010-D-0283-0010 Agency : FDA -
Sep 23,2010 11:59 PM ET
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Arnold & Porter LLP - Comment
Posted : 10/04/2010 ID ：FDA-2010-D-0283-0011 Agency : FDA -
Sep 23,2010 11:59 PM ET
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PhRMA - Comment
Posted : 10/05/2010 ID ：FDA-2010-D-0283-0012 Agency : FDA -
Sep 23,2010 11:59 PM ET
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PCAS - Comment
Posted : 10/05/2010 ID ：FDA-2010-D-0283-0013 Agency : FDA -
Sep 23,2010 11:59 PM ET
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Teva Pharmaceutical Industries Ltd. - Comment
Posted : 10/05/2010 ID ：FDA-2010-D-0283-0014 Agency : FDA -
Sep 23,2010 11:59 PM ET
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Dr. VASU POLEMERA - Comment
Posted : 10/05/2010 ID ：FDA-2010-D-0283-0015 Agency : FDA -
Sep 23,2010 11:59 PM ET
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Colorcon - Comment
Posted : 10/05/2010 ID ：FDA-2010-D-0283-0016 Agency : FDA -
Sep 23,2010 11:59 PM ET
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GlaxoSmithKline - Comment
Posted : 10/05/2010 ID ：FDA-2010-D-0283-0017 Agency : FDA -
Sep 23,2010 11:59 PM ET
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Novartis Pharmaceuticals Corp. - Comment
Posted : 10/05/2010 ID ：FDA-2010-D-0283-0018 Agency : FDA -
Sep 23,2010 11:59 PM ET
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Parenteral Drug Association (PDA) - Comment
Posted : 10/05/2010 ID ：FDA-2010-D-0283-0019 Agency : FDA -
Sep 23,2010 11:59 PM ET
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Vertex Pharmaceuticals Incorporated - Comment
Posted : 10/05/2010 ID ：FDA-2010-D-0283-0020 Agency : FDA -
Sep 23,2010 11:59 PM ET
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Millennium Pharmaceuticals, Inc. - Comment
Posted : 10/05/2010 ID ：FDA-2010-D-0283-0021 Agency : FDA -
Sep 23,2010 11:59 PM ET
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Pfizer Inc. - Comment
Posted : 10/05/2010 ID ：FDA-2010-D-0283-0022 Agency : FDA -
Sep 23,2010 11:59 PM ET
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Hospira - Comment
Posted : 10/05/2010 ID ：FDA-2010-D-0283-0023 Agency : FDA -
Sep 23,2010 11:59 PM ET
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David Robert Schoneker - Comment
Posted : 10/05/2010 ID ：FDA-2010-D-0283-0024 Agency : FDA -
Sep 23,2010 11:59 PM ET
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Eisai, Inc. - Comment
Posted : 10/05/2010 ID ：FDA-2010-D-0283-0025 Agency : FDA -
Sep 23,2010 11:59 PM ET
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Biotechnology Industry Organization (BIO) - Comment
Posted : 10/05/2010 ID ：FDA-2010-D-0283-0026 Agency : FDA -
Sep 23,2010 11:59 PM ET
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Takeda Global Research & Development Center, Inc. - Comment
Posted : 10/05/2010 ID ：FDA-2010-D-0283-0027 Agency : FDA -
Sep 23,2010 11:59 PM ET
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U.S. Pharmacopeia (USP) - Comment
Posted : 11/01/2010 ID ：FDA-2010-D-0283-0028 Agency : FDA -
Sep 23,2010 11:59 PM ET
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Parenteral Drug Association (PDA) - Comment
Posted : 11/01/2010 ID ：FDA-2010-D-0283-0029 Agency : FDA -
Sep 23,2010 11:59 PM ET