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  1. Development & Approval Process (Drugs)

Clinical Outcome Assessments Qualification Program- Resources by Stage

Clinical Outcome Assessments Qualification Program- Resources by Stage

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.

COA Qualification Program Web Resources:

  • Qualification Process- learn more about the qualification process including its 3 stages.

  • Submission Procedures- contains instructions for submitting to the COA Qualification Program.

  • Transparency Provisions- learn about the transparency provisions that apply to requestors’ submissions and FDA’s formal written determinations in response to such submissions.

  • 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.

  • Additional DDT Resources- additional resources that may be informative to your exploration of COAs and the COA Qualification Program.

COA Qualification Program Stages and Submissions:

Stage Document
Stage 1 Letter of Intent (LOI)
Stage 2 Qualification Plan (QP)
Stage 3 Full Qualification Package (FQP)

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