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

Clinical Outcome Assessments (COA) 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:

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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