Why is CDER developing DDT Qualification Programs?
DDT acceptance in the drug development and regulatory review process has previously been on a sponsor-by-sponsor, drug-by-drug basis. DDTs developed for specific drug applications are typically not publicly available. Drug sponsors seeking to use specific DDTs have typically developed enough data to justify its use only in that one setting. Generalized applicability of DDTs across varied drug development programs is often left undetermined thereby limiting an expanded use of the tool. Furthermore, development of a DDT may require a substantial investment of resources and time to develop sufficient data to justify generalized use of DDTs.
The DDT qualification process creates a collaborative setting where multiple interested parties may pool their resources and data to decrease cost, expedite drug development, and facilitate regulatory review. Increased public availability of qualified DDTs for specific contexts of use is anticipated to benefit the public health through (1) increased availability of effective drugs, (2) earlier access to medical therapies and (3) an enhanced knowledge of the drug under development
Who is eligible to contact CDER regarding the Qualification Programs?
The DDT Qualification Programs engage with submitters from industry, academia, vendors (CROs), government agencies, and foundations. Any individual or group can contact CDER for consideration and discussion of potential DDTs and the value they could bring to drug development.
What is the process for the Qualification Programs?
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.
Who comprises the QRT?
The QRT is comprised of a multidisciplinary group of FDA staff. Each team is recruited based upon the specific DDT and the context of use proposed by the submitter.
How is the DDT qualification decision made publicly available?
Once a DDT is qualified, CDER will publish a notice of the qualification decision in the Federal Register. The final DDT-specific qualification will be published as DDT-specific guidance in the form of an addendum to the Qualification Process for Drug Development Tools Guidance. Supporting documents will be posted on this website.
How can a Submitter enter into one of the Qualification Programs?
Each DDT program has its own point of contact. For contact information please see the link (add hyperlink)
Are there fees associated with a qualification submission?
At this time, there are no fees associated with the DDT Qualification Programs.
Is qualification required to enable use of a DDT in a drug development program?
No. A DDT can be used in a drug development program without it going through the qualification programs. The use of non-qualified DDTs will be reviewed by the relevant CDER Division(s) as part of IND, NDA or BLA reviews.
Qualification is recommended for a DDT that has the potential to be used in multiple drug development programs. In this instance, qualification may reduce duplication of efforts, allow resource and information sharing, and facilitate regulatory acceptance of the DDT for future applications utilizing the same context of use.
Should multiple related DDTs be submitted as a single submission or as separate submissions?
Multiple DDTs should be submitted as separate submissions even if they are related.
Is there an opportunity to expand a previous context of use for a DDT?
The qualified context of use for a DDT defines the boundaries within which the data, available at the time of initial qualification, adequately justify the use of the DDT. We encourage DDT submitters to be judicious in scope with regard to the context of use proposed in their initial submission. As data from additional studies are obtained over time, submitters of DDTs will be able to continue working within the DDT Qualification Programs to submit additional data and expand the qualified context of use.