Division of Clinical Outcome Assessment (DCOA)
Mission
Integrating the patient voice into drug development through COA endpoints that are meaningful to patients, valid, reliable and responsive to treatment.
General Information
- DCOA: Who We are and What We Do
- Clinical Outcome Assessments (COA): Frequently Asked Questions
- DCOA Contact Information
CDER COA Qualification Program
- CDER COA Qualification Program Overview
- CDER COA Qualification Program FAQs
- CDER COA Qualification Program Resources
- 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 Measures: Use in Medical Product Development to Support Labeling Claims - 2009
- BEST (Biomarkers, EndpointS, and other Tools) Resource - glossery of terms related to biomarkers, COAs and other tools
- CDER Patient- Focused Drug Development
Resources for You
- To locate a project or a qualified COA, please use the CDER & CBER’s DDT Qualification Project Search database
- COA Compendium Frequently Asked Questions (FAQs)
- COA Educational Resources and Publications of Interest
- Drug Development Tools
- CDER Patient-Focused Drug Development
- Information for Industry (Drugs)
- Office of New Drugs