DDTs are qualified through a 3-stage process: the initiation stage, consultation and advice stage, and the review stage.
• The initiation stage begins the process of submitting a biomarker for qualification. During the initiation stage, a potential submitter initiates communication with CDER regarding intentions to prepare a DDT submission. CDER then provides advice and information to the potential submitter to increase the probability of an adequate Letter of Intent (LOI) submission. After the submitter prepares and delivers the LOI, CDER acknowledges receipt of the submitters’ LOI, reviews the LOI, and makes a determination regarding its acceptability. CDER then communicates its decision to the submitter.
• The consultation and advice stage is an iterative process. This stage provides the opportunity for interactions with CDER regarding DDT development. The Qualification Review Team (QRT) evaluates study designs, information that would support the unmet need for the qualification of the DDT in the targeted context of use, and summary of analyses of data. Feedback from the QRT will be provided to the submitters to ensure completeness of the final submission for DDT qualification.
• In the review stage, the QRT reviews the qualification package and recommends a qualification decision. The CDER Director is the final signatory authority for qualification decisions. If the DDT is qualified, CDER then publishes the DDT-specific qualification as a Draft-Guidance appendix to the DDT Qualification Process guidance. The appropriately redacted supporting documents (e.g., the executive summary and the reviews) will contain an assessment of the data submitted for qualification, the conclusions that were drawn from the data, and information relevant to the use of the qualified DDT for its specific context of use.
