BLA

Results: 1118



#Item
801Chemistry / Pharmaceutical industry / Validity / Quality / Validation / Mass spectrometry software / Chromatography / Food and Drug Administration / Regulatory requirement / Science / Clinical research / Research

Dennis M. Erb, Ph.D. Senior Director Regulatory Affairs Merck & Co., Inc. BLA-20

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Source URL: www.fda.gov

Language: English - Date: 2000-12-11 11:50:15
802

TEL_verticalt_blå_h_pos_3D_4cp_200mm_Pos_dif1pt

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Source URL: www.telenor.dk

Language: Danish - Date: 2014-10-08 06:51:04
    803Clinical research / Clinical Data Management / Pharmaceutical industry / Medical informatics / Electronic Common Technical Document / Common Technical Document / Title 21 CFR Part 11 / Electronic submission / Center for Biologics Evaluation and Research / Food and Drug Administration / Medicine / Research

    SOPP 8422: Processing of Trans-BLA Submissions Version #1 Effective Date: April 18, 2011 I. Purpose The purpose of this document is to provide guidance to Center for Biologics Evaluation and

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    Source URL: www.fda.gov

    Language: English
    804Evidence / Chest radiograph / X-ray / Medicine / Black Lung Benefits Act / Coal mining in the United States

    BRB No[removed]BLA RALPH WEBBER Claimant-Petitioner v. PEABODY COAL COMPANY Employer-Respondent

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    Source URL: www.dol.gov

    Language: English - Date: 2006-07-06 14:48:41
    805

    TEL_verticalt_blå_h_pos_3D_4cp_200mm_Pos_dif1pt

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    Source URL: www.telenor.dk

    Language: Danish - Date: 2014-10-08 06:51:04
      806

      TEL_verticalt_blå_h_pos_3D_4cp_200mm

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      Source URL: www.telenor.dk

      Language: Danish - Date: 2014-10-08 06:51:05
        807Blood / Hematology / Clinical research / Pharmaceutical industry / Childbirth / Cord blood / CD34 / Blood transfusion / Validation / Biology / Medicine / Anatomy

        BLA #: [removed]Teleconference Date: June 28, 2011 FDA Attendees: Quagraine, Mercy; Karandish, Safa; McCright, Brenton; Bauer, Steven; Ghosh, Joydeep; Joshi, Bharat; Norwood, Laurie; Heidaran, Mohammad; Wang, Gang; Benton,

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        Source URL: www.fda.gov

        Language: English
        808Food and Drug Administration / Clinical pharmacology / Pharmacology / Therapeutics / United States Public Health Service / Premarket approval / Fee / Medical device / Income tax in the United States / Medicine / Health / Technology

        APPENDIX B NUMBER OF FEES PAID IN FY 2012 MDUFA established fee rates for PMA and BLA fees and for annual establishment registration fees. The rates for all other fees are statutorily set as a percent of the full PMA fee

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        Source URL: www.fda.gov

        Language: English
        809Black Lung Benefits Act / Coal mining in the United States / Lawsuit

        BRB No[removed]BLA JUANITA SPANGLER (o/b/o the Estate of FRED SPANGLER) Claimant-Respondent v. DONNA KAY COAL COMPANY,

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        Source URL: www.dol.gov

        Language: English - Date: 2010-08-04 16:09:57
        810

        TEL_verticalt_blå_h_pos_3D_4cp_200mm

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        Source URL: www.telenor.dk

        Language: Danish - Date: 2014-10-08 06:51:05
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