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.

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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

• COA Compendium
• COA Compendium Frequently Asked Questions (FAQs)

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

 

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