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  5. Clinical Outcome Assessments (COA) Qualification Program Resources
  1. Drug Development Tool (DDT) Qualification Programs

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.

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)

Resources for You

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