About FDA

Clinical Outcome Assessments Staff

The Clinical Outcome Assessments (COA) Staff is located in the Office of New Drugs’ (OND) Immediate Office, in FDA’s Center for Drug Evaluation and Research (CDER)

Our Mission

Integrating the patient voice into drug development through COA endpoints that are meaningful to patients, valid, reliable and responsive to treatment

What We Do

  • Engage with internal and external stakeholders to advance good scientific COA standards and policy development

  • Provide consultation and advice on COA development, validation, interpretation and communication of COA endpoints used in clinical trials for medical product development.

  • Address unmet medical needs by managing and leading the CDER COA Qualification Program  


Contact Us

Mailing Address:
Food and Drug Administration
Center for Drug Evaluation and Research
Office of New Drugs, Clinical Outcome Assessments Staff
10903 New Hampshire Avenue, Building 22
Silver Spring, MD 20993
Phone: 301-796-0900

Page Last Updated: 11/28/2018
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