The FDA Data Standards Advisory Board 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 Catalog: The spreadsheet provides a listing of supported and/or required standards, their uses, the date FDA will begin (or has begun) to support a particular standard, and the date support ends (or will end), the date the requirement to use a particular standard will begin (or has begun) and the date such requirement ends (or will end), as well as other pertinent information. For Centers other than CBER and CDER there may be additional supported standards, please check with the specific Center.
Please note that the first tab in the spreadsheet includes instructions.
Draft Data Standards Resources
PQ/CMC 2022 Federal Register Notice – Data Elements & Terminologies Document (PDF - 2 MB)
Data Standards Resources
- Structured Product Labeling
- Individual Case Safety Report
- Regulated Product Submission
- Study Data Standards
- Substance Registration System - Unique Ingredient Identifier (UNII)
- Federal Medication Terminology hosted by NCI Enterprise Vocabulary Services
- FDA Terminology hosted by NCI Enterprise Vocabulary Services