A new guidance from the U.S. Food and Drug Administration (FDA) offers the agency’s latest thinking on the qualification process for drug development tools (DDTs), defined as the methods, materials, or measures that can aid drug development and regulatory review.
“Encouraging the identification and use of reliable DDTs can significantly advance the development of new, safe, and effective drugs,” FDA says in the new guidance. “Qualified DDTs allow integration of innovative technology and approaches to condition or diseases that may create opportunities in new areas of drug development as knowledge of disease and pathogenesis, advances.”
Example: Using a DDT to enrich a study population with individuals exhibiting certain characteristics may help to reduce the size of the study population and may shorten the duration of the study.
Within an appropriate context of use (COU), a qualified DDT may be used to support or obtain approval or licensure of any drug or biological product, provided the qualification has not been rescinded or modified. Seeking qualification of a DDT for a specified COU is voluntary.
FDA currently has DDT qualification programs for biomarkers, clinical outcome assessments (COAs), and animal models. The FDA defines a COA as a “measure of a patient’s symptoms, overall mental state, or the effects of a disease or condition on how the patient functions.”
For more information on how DDTs can benefit drug development, visit the FDA’s Drug Development Tools and Drug Development Tool Qualification Process: Transparency Provisions web pages.
Author: Michael Causey