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FDA Resources for Data Standards
The FDA Data Standards Council coordinates the evaluation, development, maintenance, and adoption of health and regulatory data standards to ensure that common data standards are used throughout the agency.
Data Standards Resources
Structured Product Labeling
Individual Case Safety Report
Regulated Product Submission
Study 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
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