International Clinical Research Center

Results: 114



#Item
91Clinical research / Pharmaceuticals policy / Drug safety / Pharmacopoeias / Medical device / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use / Center for Biologics Evaluation and Research / Health Canada / Medicine / Health / Food and Drug Administration

Microsoft Word - 8923fnl.doc

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Source URL: www.fda.gov

Language: English
92Food and Drug Administration / Pharmacology / Clinical Data Management / Common Technical Document / Center for Biologics Evaluation and Research / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use / Center for Drug Evaluation and Research / Good Laboratory Practice / Biologic / Clinical research / Research / Medicine

Guidance for Industry M4: The CTD - Safety Questions and Answers

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Source URL: www.fda.gov

Language: English
93Clinical Data Management / Food and Drug Administration / Drug safety / Medical informatics / Electronic Common Technical Document / Common Technical Document / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use / Center for Biologics Evaluation and Research / Center for Drug Evaluation and Research / Medicine / Research / Clinical research

Guidance for Industry M2: eCTD Specification Questions & Answers and Change Requests

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Source URL: www.fda.gov

Language: English
94Clinical research / Pharmacology / Pharmaceuticals policy / Drug safety / Center for Biologics Evaluation and Research / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use / Pharmacopoeia / Biologic / Center for Drug Evaluation and Research / Medicine / Food and Drug Administration / Health

Microsoft Word - 8079fnl.doc

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Source URL: www.fda.gov

Language: English
95Electrophoresis / Molecular biology / Food and Drug Administration / Clinical research / Pharmaceuticals policy / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use / Center for Biologics Evaluation and Research / Pharmacopoeia / Polyacrylamide / Chemistry / Biology / Medicine

Microsoft Word - 9117fnl.doc

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Source URL: www.fda.gov

Language: English
96Research / Pharmaceuticals policy / Drug safety / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use / Pharmacopoeias / Food and Drug Administration / Environmental Working Group / Center for Biologics Evaluation and Research / Alternative medicine / Medicine / Health / Clinical research

Microsoft Word - 8078fnl.doc

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Source URL: www.fda.gov

Language: English
97Food and Drug Administration / Pharmaceutical industry / Clinical Data Management / Drug safety / Common Technical Document / New Drug Application / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use / Drug Master File / Center for Biologics Evaluation and Research / Clinical research / Research / Medicine

Guidance for Industry Submitting Marketing Applications According to the ICH-CTD Format —

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Source URL: www.fda.gov

Language: English
98Pharmaceuticals policy / Clinical research / Food and Drug Administration / Pharmacopoeias / United States Public Health Service / Center for Biologics Evaluation and Research / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use / Medicine / Health / Pharmaceutical sciences

Microsoft Word - 11114fnl_10[removed]doc

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Source URL: www.fda.gov

Language: English
99Food and Drug Administration / Pharmaceuticals policy / Clinical research / Pharmacopoeias / United States Public Health Service / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use / Center for Biologics Evaluation and Research / Health Canada / Medicine / Health / Pharmaceutical sciences

Microsoft Word - 8922fnl.doc

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Source URL: www.fda.gov

Language: English
100Research / Pharmacology / Clinical research / Pharmacopoeias / Pharmaceuticals policy / Center for Biologics Evaluation and Research / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use / Biologic / Center for Drug Evaluation and Research / Medicine / Food and Drug Administration / Health

Microsoft Word - 8669fnl.doc

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Source URL: www.fda.gov

Language: English
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