Clinical Outcome Assessments (COA) Staff
Mission
Integrating the patient voice into drug development through COA endpoints that are meaningful to patients, valid, reliable and responsive to treatment.
The Office of New Drugs is undergoing a reorganization. This site may be updated in the near future. Please check back often. For more information, please visit Reorganization of the Office of New Drugs with Corresponding Changes to the Office of Translational Sciences and the Office of Pharmaceutical Quality.
General Information
- COA Staff: Who We are and What We Do
- Clinical Outcome Assessments (COA): Frequently Asked Questions
- COA Staff Contact Information
CDER COA Qualification Program
- CDER COA Qualification Program Overview
- CDER COA Qualification Program FAQs
- CDER COA Qualification Program Resources by Stage
- Qualified COAs
- CDER COA Qualification Program Submissions
COA Compendium
Guidances and Other Resources
- COA Educational Resources and Publications of Interest
- (FDA Guidance) Patient Reported Outcome COA: Use in Medical Product Development to Support Labeling Claims
- BEST (Biomarkers, EndpointS, and other Tools) Resource
- CDER Patient- Focused Drug Development
Resources for You
- Drug Development Tools
- CDER Patient-Focused Drug Development
- Information for Industry (Drugs)
- Office of New Drugs