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
