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 Catalog (XLS) 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.
Data Standards Resources
Structured Product Labeling
Individual Case Safety Report
Regulated Product Submission
Study Data Standards
Federal Register Notice - Request for Comments for the Draft Standardization of Pharmaceutical Quality/Chemistry Manufacturing and Control Data Elements and Terminologies
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