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What is Drug Development Tool Qualification? Is it Part of the Critical Path?

January 13, 2021  •  Blog  •  Christopher Scull, Senior Consultant
Posted In Other News & Insights  •  Tagged Regulatory, FDA Innovation, Qualification

A new guidance from FDA last month may be adding to confusion in industry regarding the difference between FDA requirements and programs that are voluntary.  At first glance, the title “Qualification Process for Drug Development Tools” might suggest that the FDA has new expectations for sponsors planning regulatory submissions such as INDs, BLAs, and NDAs.  However, the confusion may arise from the different perceptions biotech companies and the FDA have when using terms like “novel technology” or “critical path.”

While every biotech company developing an investigational product is intently focused on the ‘critical path,’ in industry this term usually refers to the activities required to enter into clinical trials or gain marketing approval.  However, as far back as 2004 the FDA established the Critical Path Initiative (CPI) which has included the opportunity for Critical Path Innovation Meetings (CPIMs) with FDA.  While it may sound like an opportunity to meet with FDA to discuss accelerating your product development, this initiative does not apply to every new technology that might diagnose, prevent, or treat a medical condition.  Rather, the initiative is focused on “creating the scientific tools and processes necessary to support 21st-Century medical product regulation.”  A CPIM would not focus on a specific product, but rather the tools that might help FDA evaluate new products more efficiently.  Examples of information to discuss at a CPIM include:

  • Biomarkers
  • Natural history study designs and implementation
  • Emerging technologies or new uses of existing technologies
  • Innovative conceptual approaches to clinical trial design and analysis

The 2016 Cares Act builds on some programs identified by the Critical Path Initiative and established new processes for qualifying Drug Development Technologies (DDTs). The FDA definition of DDTs includes “methods, materials, or measures that can aid drug development and regulatory review.”  Examples include biomarkers, clinical outcome assessments (COAs), and certain animal models.  DDTs that FDA has “qualified” (or accepted) can be relied upon to have a specific interpretation and application in medical product development and regulatory review.  The new November 2020 guidance on DDT Qualification describes the process for qualification of DDTs that are either biomarkers, COAs, or animal models.

Note, however, that a DDT does not have to be qualified to be used in a product development program or regulatory application, and qualification of novel DDTs is voluntary.  Therefore, when considering DDT Qualification, the concept of a ‘novel technology’ should be considered with respect to whether the new technology is broadly applicable to regulatory science.  If you are developing a novel technology that can be applied to diagnosis or treatment of a specific condition or disease, the conventional pathways of developing an investigational product for approval with an NDA or BLA are most relevant to your program.  Development of an investigational product will likely include some assay qualification.  By contrast, if you are developing a new tool that might enhance regulatory review processes, then FDA has programs in place to foster the development of that technology, and DDT Qualification is one such opportunity.

Food and Drug Administration (FDA). (2020). Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff Retrieved from source