Clinical Outcome Assessments (COA) Qualification Program Resources
COAQP Email Updates
Subscribe for COAQP emails. Receive timely communications such as procedural changes, newly qualified COAs and other COAQP related announcements.
COAQP Stages and Submissions
| Stage | Content Element Outlines |
|---|---|
| Stage 1 | Letter of Intent (LOI) |
| Stage 2 | Qualification Plan (QP) |
| Stage 3 | Full Qualification Package (FQP) |
- COAQP Orientation Session- a recorded webinar that we highly encourage interested participants to view to learn valuable information related to the qualification process requirements. You may download the slide deck. We also encourage folks to read FDA’s final guidance, Qualification Process for Drug Development Tools - Guidance for Industry and FDA Staff.
- 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.
- COA Qualification program submissions and qualified COAs can be viewed using the CDER & CBER Drug Development Tool Qualification Project Search Database. Previous webpage materials related to COA Qualification Program Submissions and Qualified COAs are no longer updated as of 2021.
- Additional DDT Resources - additional resources that may be informative to your exploration of COAs and the CDER COA Qualification Program.