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.
Qualification Process-contains an overview of the qualification process as well as a link to 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.
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 CDER COA Qualification Program.
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
- CDER COA Qualification Program Overview
- CDER COA Qualification Program FAQs
- Qualified COAs
- CDER COA Qualification Program Submissions
- DCOA Homepage
- Drug Development Tools