On December 13, 2016, Qualification of Drug Development Tools (DDT), was added to the Federal Food, Drug, and Cosmetic Act. Section 507 via 21st Century cure legislation.
When human efficacy studies are not feasible or ethical, FDA allows approval of life saving drugs based on evaluation of clinical outcomes, biomarkers or animal studies data under the purview of Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).
“For supporting the qualification of DDTs that are out of scope of existing DDT qualification, The Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program was launched.”
Some examples of such DDT may include telemedicine - clinician reported outcomes (ClinROs), digital photography, tissue chips, micro physiological models, artificial intelligence algorithms and others that can harness the power of modern invitro and computational technologies to accelerate the development of drugs and biologics. In addition, they will be able to vastly reduce or replace the use of animal testing.
Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program Submission Process
Submission to ISTAND follows similar track as biomarkers and COA which is a 3 step qualification process which includes Letter of Intent (LOI), Qualification Plan (QP) and Full Qualification Package (FQP). The DDT is evaluated based on 1) scientific merit 2) ability of the DDT to address a specified drug development need 3) availability of information and resources that support the proposed qualification effort 4) demonstration that the DDT is feasible and practical.
In case this is not appropriate, other avenues like FDA guidance's, public meetings, meetings with agency staff, or “white papers” may be explored.
Once qualified, the DDTs will be available to use in any drug development program for the qualified context of use and may be included in IND, NDA, or BLA applications.
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