On This Page Date: July 18, 2025 Time: 9:00 a.m. – 4:00 p.m. ET What is an advisory committee? Advisory committees provide independent expert advice to […]

Below are CDER’s COA Qualification Program’s frequently asked questions (FAQs). We also recommend reviewing the general COA FAQ web page. General CDER COA Qualification Program Information […]

The table below lists qualified Clinical Outcome Assessments (COA). The tables include legacy projects (those submitted prior to passage of the 21st Century Cures Act), as […]

How to engage with the Biomarker Qualification Program (BQP) If you have pre-submission or general inquiry questions or you want to make a meeting request, please […]

The tables below list information about submissions to the FDA Clinical Outcome Assessments (COA) Qualification Program for which final COA qualification determinations have not yet been […]

Under the 21st Century Cures Act,1 enacted on December 13, 2016, a new section 507, Qualification of Drug2 Development Tools (DDT)3, was added to the Federal […]

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