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Pharmaceutical industry / Pharmacology / Clinical Data Management / Pharmaceuticals policy / Validation / Drug Master File / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use / Common Technical Document / HTML element / Clinical research / Research / Pharmaceutical sciences


Guidance for Industry M4: The CTD — Quality Questions and Answers/
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City

Rockville / /

Company

CTD-Quality Implementation Working Group / /

Country

Japan / United States / /

Facility

Rockville Pike / /

IndustryTerm

manufacturing facility / drug product / manufacturing sites / manufacturing schemes / drug products / manufacturing processes / manufacturing information / routine manufacturing control / /

MedicalCondition

blister / PVC blister / transmissible spongiform encephalopathy agents / unit-dose blister / /

Organization

U.S. Department of Health and Human Services / Food and Drug Administration Center for Drug Evaluation and Research / Training and Communication Division of Drug Information / Food and Drug Administration / office of Training / 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 / /

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Position

A. GENERAL / General Information S.1.1 Nomenclature / General / /

Product

M-16 / Appendix 3.2.A.1 / /

ProvinceOrState

Maryland / /

Technology

prions / /

URL

http /

SocialTag