Anda

Results: 752



#Item
591Clinical research / Clinical Data Management / Drug safety / Medical informatics / Abbreviated New Drug Application / Electronic Common Technical Document / New Drug Application / Common Technical Document / Food and Drug Administration / Research / Pharmaceutical sciences / Pharmaceutical industry

Overview: Draft Guidance for Industry ANDA Submissions - Content and Format of Abbreviated New Drug Applications Elizabeth Giaquinto, JD

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Source URL: www.fda.gov

Language: English
592Anda

DMFs from a GDUFA Perspective

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Source URL: www.fda.gov

Language: English
    593

    [1] Ketahuilah Hak-Hak Anda Teleponlah salah satu nomor sambungan cepat dalam brosur ini jika Anda memerlukan bantuan Anda menerima brosur ini karena memohon visa non-imigran untuk bekerja atau belajar

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    Source URL: photos.state.gov

    Language: Indonesian - Date: 2011-08-10 10:44:19
      594

      Apakah Hari Pantauan Air Sedunia? Ia Menyeronokkan... Anda boleh melakukannya bersama kelas, keluarga, rakan, atau sukarelawan lain.

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      Source URL: www.worldwatermonitoringday.org

      Language: Indonesian - Date: 2013-10-29 16:10:54
        595Clinical research / Food and Drug Administration / Drug safety / New Drug Application / Fee / Anda / Drug Master File / Pharmaceutical sciences / Pharmaceutical industry / Pharmacology

        Completeness Assessment for Type II DMF Under GDUFA

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        Source URL: www.fda.gov

        Language: English
        596Pharmaceutical industry / Clinical Data Management / Medical informatics / Drug safety / Electronic Common Technical Document / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use / Drug Master File / Abbreviated New Drug Application / Food and Drug Administration / Clinical research / Research / Medicine

        Optimizing your eCTD ANDA

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        Source URL: www.fda.gov

        Language: English
        597Medical informatics / Clinical Data Management / Electronic Common Technical Document / Competitions / Digital media / Abbreviated New Drug Application / Food and Drug Administration / Electronic submission / Regulated Product Submissions / Research / Clinical research / Medicine

        Johnny Young Office of Generic Drugs/Division of Labeling and Program Support An Overview of the Draft Guidance for Industry ANDA

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        Source URL: www.fda.gov

        Language: English
        598Pharmaceuticals policy / Drug safety / Food and Drug Administration / Pharmaceutical industry / Over-the-counter drug / Emergency contraception / Generic drug / New Drug Application / Off-label use / Medicine / Pharmacology / Pharmaceutical sciences

        DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration Rockville, MD[removed]Dear NDA/ANDA Applicant: This letter is intended to document and communicate FDA’s determinations regarding the scope

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        Source URL: www.hpm.com

        Language: English - Date: 2014-02-25 16:53:28
        599Health / Drug Master File / Food and Drug Administration / Pharmaceuticals policy / Abbreviated New Drug Application / Federal Food /  Drug /  and Cosmetic Act / Anda / Pharmaceutical sciences / Pharmaceutical industry / Medicine

        Huyi Zhang, Ph.D. DMF Review Staff, OGD Completeness Assessment for Type II Active Pharmaceutical Ingredient Drug Master Files

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        Source URL: www.fda.gov

        Language: English
        600Research / Clinical research / Pharmacology / Drug safety / New Drug Application / Anda / Center for Drug Evaluation and Research / Food and Drug Administration / Pharmaceutical sciences / Pharmaceutical industry

        Letter - Anticoagulant Citrate Dextrose Solution Formula A, Gambro BCT Inc.

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        Source URL: www.fda.gov

        Language: English
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