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Clinical Data Management / Pharmacology / Common Technical Document / Pharmaceuticals policy / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use / Electronic Common Technical Document / Clinical trial / Food and Drug Administration / Research / Clinical research / Pharmaceutical sciences


Guidance for Industry M4: Organization of the CTD U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER)
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City

Rockville / /

Continent

Europe / /

Country

Japan / United States / /

Facility

Rockville Pike / /

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IndustryTerm

pharmaceuticals / drug product / human pharmaceuticals / biotechnology-derived products / pharmaceutical / drug products / /

MedicalCondition

pneumonia / /

Organization

International Committee of Medical Journal Editors / U.S. Department of Health and Human Services / Food and Drug Administration Center for Drug Evaluation and Research / Training and Communications Division of Drug Information / Food and Drug Administration / office of Training / Organization of the CTD Copies / 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 / ICH Steering Committee / Center for Biologics Evaluation and Research / Center for Biologics Evaluation and Research Food and Drug Administration / office of Communication / Training and Manufacturers Assistance / /

Person

Summaries Module / /

/

Position

General / /

Product

M-16 / /

ProvinceOrState

Maryland / /

Technology

Pharmacokinetics / biotechnology / Quality of Service / /

URL

http /

SocialTag