Clinical Outcome Assessments (COA) Qualification Program Resources
Below we provide resources to assist requestors and those interested in the CDER COA Qualification Program. If you have questions, please contact the CDER COA Qualification Program at: COADDTQualification@fda.hhs.gov.
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Qualification Process-contains an overview of the qualification process as well as a link to FDA’s draft guidance, Qualification Process for Drug Development Tools - Guidance for Industry and FDA Staff.
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Submission Procedures- contains instructions for submitting to the COA Qualification Program.
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Transparency Provisions- learn about the transparency provisions that apply to requestors’ submissions and FDA’s formal written determinations in response to such submissions.
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Qualified COAs and COA Qualification Program Submissions- contain a list of qualified COAs and a list of COAs in the qualification program for which qualification decisions have yet to be made. These lists also contain information about these COAs’ submissions.
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Additional DDT Resources - additional resources that may be informative to your exploration of COAs and the CDER COA Qualification Program.
COA Qualification Program Stages and Submissions:
| Stage | Content Element Outlines |
|---|---|
| Stage 1 | Letter of Intent (LOI) |
| Stage 2 | Qualification Plan (QP) |
| Stage 3 | Full Qualification Package (FQP) |