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Food 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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City

Rockville / /

Company

CTD-Safety Implementation Working Group / /

Country

Japan / United States / /

Facility

Rockville Pike / /

Organization

U.S. Department of Health and Human Services / HFD-240 Center for Drug Evaluation / U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research / European Union / Food and Drug Administration Center for Drug Evaluation and Research / Training and Communication Division of Drug Information / Food and Drug Administration / ICH Steering Committee / Center for Biologics Evaluation and Research / office of Training / Center for Biologics Evaluation and Research Food and Drug Administration / office of Communication / Training and Manufacturers Assistance / /

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Product

M-16 / /

ProvinceOrState

Maryland / /

Technology

drug development / /

URL

http /

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