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For Industry
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FDA Resources for 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.
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
Validators
Consolidated Health Informatics
- Annotated ECG Waveform Data
- Structured Product Labeling
- Individual Case Safety Report
- Stability Regulated Product Submission
Clinical Data Interchange Standards Consortium
- Study Data Tabulation Model
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