COAQP Email Updates
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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)|
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.