Published COAs that have the potential to be used to support efficacy endpoints in treatment trials for rare diseases. Learn more About Certificates of Analysis.
COA Search
Additional Information
FDA Resources
- Clinical Outcome Assessment (COA): Frequently Asked Questions
- Clinical Outcome Assessment Compendium
- Condition-Specific Meeting Reports and Other Information Related to Patients’ Experience
- Assessment of the Use of Patient Experience Data in Regulatory Decision-Making
- Multiple Endpoints in Clinical Trials Guidance for Industry
- FDA Patient-Focused Drug Development Guidance Series
- FDA Drug Development Resources for the Rare Disease Community and More
- Search for FDA Guidance Documents
