The 21st Century Cures Act formally established a multi-step process for Drug Development Tools (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).
Letter of Intent (LOI)
Following receipt of a completed LOI, ISTAND Pilot Program staff will review the letter and provide the applicant with information as to whether the submission has been admitted into the pilot and will progress to technical review. Admittance will be based on submission quality, drug development need, technology feasibility, and subject matter expert capacity. As this is a pilot program, capacity may be limited.
If an LOI is admitted for review, the applicant may be invited to present to the review staff. All such meeting proceedings will be confidential, and all discussions will be non-binding.
Following subject matter expert review, the DDT Committee makes the determination to accept or not accept a submission into the program based on several factors, including: the scientific merit of the submission, the ability of the DDT to address a specified drug development need, the availability of information and resources that support the proposed qualification effort, and demonstration that the DDT is feasible and practical. Although ISTAND’s goal is to qualify novel drug development tools for use in drug development programs, for some novel DDTs, qualification may not be the optimal path forward. In these cases, ISTAND will assist requestors and Agency subject matter experts to find the best path forward (e.g., guidance development or public meeting).
A determination to accept an LOI or a QP submission indicates that the requestor may proceed to the next stage, the QP or FQP, respectively, provided the requestor addresses the recommendations and comments in the Determination Letter. Applicants may not proceed from the LOI or QP stage to the next stage unless they are accepted at these stages.