Who We Are
The Clinical Outcome Assessments (COA) Staff comprises multidisciplinary measurement experts and is located in the Office of New Drugs’ (OND) Immediate Office, in FDA’s Center for Drug Evaluation and Research (CDER). To support CDER’s mission for patient-focused drug development, we provide leadership, expertise, and advice to promote the use of patient-focused outcome assessments.
What We Do
- Play a central role in promoting innovative, science-based review of COA development, validation, interpretation and communication of COA endpoints throughout the drug development life-cycle.
- Engage with internal and external stakeholders to advance good scientific COA standards and policy development.
- Address unmet medical needs by managing and leading the CDER COA Qualification Program.
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