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  1. Development & Approval Process | Drugs

Drug Development Tool Qualification Programs

Drug1 Development Tools (DDTs) are methods, materials, or measures that have the potential to facilitate drug development. Examples of DDTs may include, but are not limited to: a biomarker2 used for clinical trial enrichment, a clinical outcome assessment (COA) used to evaluate clinical benefit, or an animal model used for efficacy testing of medical countermeasures under the regulations commonly referred to as the Animal Rule3.

To support DDT development efforts, FDA established qualification programs for animal models for use under the Animal Rule, biomarkers, and clinical outcome assessments.

Mission and Objectives of the DDT Qualification Programs:

  • To qualify and make DDTs publicly available for a specific context of use to expedite drug development and review of regulatory applications
  • To provide a framework for early engagement and scientific collaboration with FDA to facilitate DDT development
  • To facilitate integration of qualified DDTs in regulatory review
  • To encourage development of DDTs for contexts of use with unmet needs
  • To encourage the formation of collaborative groups to undertake DDT development programs to increase the efficiency and lessen the individual resource burden incumbent with DDT development
  • To encourage innovation in drug development
  • To create a shared learning environment for exchanging information on DDT development

What is Qualification?

Qualification is a conclusion that within the stated context of use, the DDT can be relied upon to have a specific interpretation and application in drug development and regulatory review. Once qualified, DDTs will be publicly available to be used in any drug development program for the qualified context of use. Additionally, the qualified DDT can be included in IND, NDA, or BLA submissions without needing FDA to reconsider and reconfirm its suitability as long as:

  • There are no serious study flaws
  • There are no attempts to apply the DDT outside the qualified context of use
  • There are no new and conflicting scientific facts not known at the time the qualification was determined

Why is FDA developing Qualification Programs?

Having qualified DDTs that can be used by many sponsors helps optimize drug development and evaluation. DDT acceptance in the drug development and regulatory review process has previously been on a sponsor-by-sponsor, drug-by-drug basis. Drug sponsors seeking to use specific DDTs have typically developed enough data to justify its use only in that one setting. Generalized applicability of DDTs across varied drug development programs is often left undetermined thereby potentially limiting an expanded use of the tool.

The resources needed to develop a DDT for a more generalized use is often beyond the capabilities of a single entity. FDA encourages forming collaborative groups, such as a public-private partnership (PPP). A PPP involves at least one non-profit organization and one for-profit organization. A variety of projects undertaken by various PPPs have demonstrated the usefulness of this approach.

These qualification programs promote a collaborative setting where multiple interested parties may pool resources and data to decrease cost, expedite drug development, and facilitate regulatory review. Increased public availability of qualified DDTs for specific contexts of use is anticipated to benefit the public health through (1) increased availability of effective drugs, (2) earlier access to medical therapies and (3) an enhanced knowledge of the drug under development.

What is Context of Use?

Context of use refers to a comprehensive description that fully and clearly delineates the limits of FDA’s qualification decision in terms of the manner and purpose of use for the DDT(s). The context of use statement should describe all criteria under which the DDT is qualified for use. The qualified context of use defines the boundaries within which the available data adequately justify use of the DDT(s). 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 A biomarker can be a single concept or a panel of multiple concepts.

3 See 21 CFR 314.600 through 314.650 for drugs and 21 CFR 601.90 through 601.95 for biological products.

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