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SOPP 8412: Review of Product Labeling Version # 4 Effective Date: April 2, 2012 I. Purpose This SOPP outlines the general operating procedures for Center for Biologics Evaluation and Research (CBER) staff to process draf
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Company

G. Chemistry Manufacturing / Microsoft / /

Facility

Bar Code Labeling Review / Institute of Medicine / Bar Code Label Requirements Questions / /

IndustryTerm

draft and final product / blood component products / advertising requirements / biological products / manufacturing product information / written labeling communications / licensed and approved products / email communications / Internet Electronic Submissions Web page / risk management / healthcare providers / drug products / benefit communications / /

MedicalCondition

MS / /

MedicalTreatment

medication errors / /

Organization

CBER SRS / Food and Drug Administration / Center for Biologics Evaluation / Institute of Medicine / FDA / US Adopted Name Council / Center for Biologics Evaluation and Research / /

Person

Job Aid / /

Position

labeling coordinator / Physician / Chair / labeling F. Non-Clinical Toxicologist / Committee Chair / RPM] d / Regulatory Project Manager / /

Product

Preventing Medication / /

ProgrammingLanguage

XML / /

PublishedMedium

the Proprietary Name Review / /

RadioStation

CBE / /

Technology

pharmacokinetics / XML / bar code / jpeg / Extensible Markup Language / pharmacodynamics / /

SocialTag