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Guidance for Industry Format and Content for the CMC Section of an Annual Report Center for Drug Evaluation and Research (CDER)
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City

Rockville / /

IndustryTerm

manufacturing / Internet using FTP / pharmaceutical industry / drug product / drug products / stability protocol / stability protocols / /

Organization

FDA / Center for Drug Evaluation and Research Guideline for Submitting Documentation for the Stability / Annual Report Center for Drug Evaluation and Research / Center for Drug Evaluation and Research / Food and Drug Administration / Chemistry Manufacturing Controls Coordinating Committee / Division of Communications Management / /

Person

Roger L. Williams / Charles Kumkumian / /

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Position

representative / /

Product

S-003 / /

ProvinceOrState

Maryland / /

Technology

approved protocol / approved stability protocol / stability protocols / D. Stability Protocol / stability protocol / /

URL

WWW.FDA.GOV/CDER / /

SocialTag