The Drug1 Development Tool (DDT) qualification process provides a framework for interactions between FDA and DDT requestors to guide the collection of data to support a DDT’s prospectively specified context of use. FDA Centers intend to interact actively with DDT requestors to advance DDT development for both drugs and biologics.
Under the 21st Century Cures Act 2, enacted on December 13, 2016, a new section 507, Qualification of Drug Development Tools (DDTs)3, was added to the Federal Food, Drug, and Cosmetic Act. Building on the qualification program that FDA had voluntarily established and implemented for many years (“the legacy qualification program”), the 21st Century Cures Act formally established a multi-step process for DDT qualification. Qualification of a DDT is for a specific context of use (COU), and the qualified DDT may be used for the COU by any person in drug or biologics development. The qualification process includes three submissions: the Letter of Intent (LOI), the Qualification Plan (QP), and the Full Qualification Package (FQP)4. Anyone interested in entering the qualification program should submit an LOI.
FDA’s goal is to transition from the legacy qualification program process to the new section 507 DDT Qualification Process through a phased approach. We are developing a transition plan for existing projects, as well as section 507 submission documents (LOI, QP, FQP).
DDT Process Guidance
CDER and CBER have issued the draft guidance, “Qualification Process for Drug Development Tools - Guidance for Industry and FDA Staff.” This draft guidance provides FDA’s current thinking regarding the qualification process for drug development tools (DDTs) for a specific context of use, as defined in the Cures Act.
The draft guidance emphasizes the value of early and ongoing interactions with FDA during the DDT development process. To encourage stakeholder involvement in DDT process development, FDA is seeking comments on the recently issued draft guidance, Qualification Process for Drug Development Tools. For information about how to submit comments and suggestions to FDA, please refer to Federal Register Docket: FDA-2010-D-0529.
For additional information on how to submit to a DDT Qualification Program, please visit: DDT Submission Process.
DDT Process Frequently Asked Questions
Who reviews a DDT submission?
The review team comprises a multidisciplinary group of FDA staff. Each team is put together based upon the specific DDT and the context of use proposed by the requestor. There is also an opportunity to consult with external experts as needed based on a tool’s context of use.
How is the DDT qualification decision made publicly available?
Once a DDT is qualified, FDA will publish the decision on its webpage along with the executive summary and redacted reviews.
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 FDA center(s), division(s), and office(s) as part of IND, NDA, or BLA reviews.
A DDT that has the potential to be used in multiple drug development programs may be considered for qualification. 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.
Is there an opportunity to expand a context of use for a previously qualified 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 requestors to be judicious in scope regarding the context of use proposed in their initial submission. As data from additional studies are obtained over time, requestors of DDTs may continue working within the DDT qualification programs to submit additional data and expand the qualified context of use.
1 The term drug refers to both human drugs and biological products unless otherwise specified.
2 Further information regarding the 21st Century Cures Act can be found at https://www.congress.gov/114/bills/hr34/BILLS-114hr34enr.pdf. The content section pertinent to this letter is Subtitle B – Advancing New Drug Therapies, Sec. 3011 Qualification of drug development tools, which is largely codified at section 507 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), or 21 U.S.C. 357.
3 Section 507 of the FD&C Act defines “drug development tool” to include biomarkers and clinical outcome assessments, and “any other method, material, or measure that the Secretary determines aids drug development and regulatory review for purposes of this section.”