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The purpose of the FDA Data Standards Council (DSC) is to
coordinate the evaluation, development, maintenance, and adoption
of health and regulatory data standards to ensure that common
data standards are used throughout the agency and the standards
are consistent with those used outside the FDA. This is accomplished
through strategically focused and systematic analysis of health
and regulatory data standards requirements, evaluation of existing
standards and adoption or development and maintenance of standards.
FDA Resources for Standards
Structured Product Labeling
Individual Case Safety Report
Regulated Product Submission
CDISC Data Standards
Stability Data Standard
Substance Registration System - Unique Ingredient
Identifier (UNII)
Federal
Medication Terminology hosted by NCI Enterprise Vocabulary
Services
FDA
Terminology hosted by NCI Enterprise Vocabulary Services
XForms
Presentations
Update on the Study Data Tabulation
Model for FDA Submissions - February 1, 2005
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