U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. Drug Development Tool (DDT) Qualification Programs
  5. Clinical Outcome Assessment (COA) Qualification Program
  6. Clinical Outcome Assessments (COA) Qualification Program Resources
  1. Clinical Outcome Assessment (COA) Qualification Program

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

Resources for You

Back to Top

Back to Top