Drug Master File

Results: 255



#Item
91Drug Master File / Dosage form / Dose / Abbreviated New Drug Application / Pharmacy / Pharmaceuticals policy / Pharmaceutical industry / Pharmaceutical sciences / Pharmacology

DOC Document

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Source URL: hc-sc.gc.ca

Language: English - Date: 2014-01-30 13:34:04
92Clinical research / Medicine / Research / Drug safety / Pharmaceuticals policy / New Drug Application / Drug Master File / Federal Food /  Drug /  and Cosmetic Act / Validation / Pharmaceutical industry / Food and Drug Administration / Pharmaceutical sciences

CMC Considerations for 505(b)(2) Applications

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Source URL: www.fda.gov

Language: English
93Pharmaceutics / Pharmaceuticals policy / Food and Drug Administration / Therapeutics / Drug Master File / Abbreviated New Drug Application / Generic drug / New Drug Application / Pharmaceutical drug / Pharmaceutical industry / Pharmaceutical sciences / Pharmacology

Microsoft Word - GDUFA Statutory Language[removed]docx

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Source URL: www.fda.gov

Language: English
94Pharmaceuticals policy / Pharmacology / Clinical research / Food and Drug Administration / Drug safety / New Drug Application / Drug Master File / Generic drug / Validation / Pharmaceutical industry / Pharmaceutical sciences / Pharmaceutics

October 11, 2013 Division of Dockets Management (HFA-305) Food and Drug Administration Department of Health and Human Services 5630 Fishers Lane Room 1061

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Source URL: www.gphaonline.org

Language: English - Date: 2014-01-15 14:02:18
95Clinical pharmacology / Food and Drug Administration / Clinical research / Drug Master File / Center for Drug Evaluation and Research / Drug discovery / Abbreviated New Drug Application / Investigational New Drug / Pharmaceutical sciences / Pharmacology / Pharmaceutical industry

Chemistry, Manufacturing, & Controls Requirements

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Source URL: www.fda.gov

Language: English
96

Drug Master File (DMF) Application Form

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Source URL: hc-sc.gc.ca

- Date: 2013-12-13 10:07:56
    97Money / Cheque / Credit card / Invoice / Bank / Wire transfer / Accounts payable / Routing transit number / Debit card / Payment systems / Business / Finance

    Drug Master File (DMF) Application Fee Form DMF OWNER/AGENT

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    Source URL: hc-sc.gc.ca

    Language: English - Date: 2014-04-01 10:19:38
    98Pharmaceutical sciences / Prescription Drug User Fee Act / Investigational New Drug / Center for Drug Evaluation and Research / Center for Biologics Evaluation and Research / Abbreviated New Drug Application / Drug Master File / Generic drug / Food and Drug Administration / Medicine / Health

    unapproved drug workshop v6

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    Source URL: www.fda.gov

    Language: English
    99

    Drug Master File (DMF) Application Form Drug Master File (DMF) Name:

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    Source URL: hc-sc.gc.ca

    - Date: 2013-12-17 07:11:28
      100Pharmacology / Research / Pharmaceutics / Food and Drug Administration / Pharmaceuticals policy / Regulatory requirement / Drug Master File / Validation / Clinical trial / Pharmaceutical industry / Pharmaceutical sciences / Clinical research

      GUIDANCE FOR INDUSTRY PREPARATION OF VETERINARY NEW DRUG SUBMISSIONS VETERINARY DRUGS DIRECTORATE HEALTH CANADA

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      Source URL: hc-sc.gc.ca

      Language: English - Date: 2013-07-26 15:35:35
      UPDATE