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  1. Development & Approval Process | Drugs

Drug Development Tool (DDT) Qualification Programs

Spotlight Events & Announcements

To locate a project or a qualified biomarker go to CDER & CBER’s DDT Qualification Project Search database

DDT Funding Announcement
*** DDT Grant cycle is now closed for FY2021. The next submission deadline is ​May 3, 2023 ***


Regulated Product(s)

  • Drugs
  • Drug Development Tools


  • ResearchLaw(s) & Regulation(s)
  • 21st Century Cures Act of 2016


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, and 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.

21st Century Cures Act Report

Section 3011(c)(2) of the 21st Century Cures Act (Cures) requires that, not later than 5 years after the date of enactment of Cures, FDA make publicly available on the Agency’s website a report.

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 generally can be included in IND, NDA, or BLA submissions without needing FDA to reconsider and reconfirm its suitability.

FDA has issued draft guidance to inform individuals and organizations interested in qualifying a DDT about the qualification process as outlined in the 21st Century Cures Act. For more information on FDA’s current thinking on the DDT qualification process please see the Qualification Process for Drug Development Tools - Guidance for Industry and FDA Staff: Draft Guidance.

Why has FDA developed a DDT Qualification Process?

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 may be achieved three ways : through an individual drug or biologic application, by being an accepted DDT in clinical use, or through the voluntary qualification process established by the 21st Century Cures Act (Cures Act). Drug sponsors seeking to use specific DDTs have typically developed enough data to justify a use, which may need to be included in each application. Outside of qualification, the applicability of DDTs across varied drug development programs may need justification. The Cures Act, passed in 2016, defined a three-stage qualification process allowing use of a qualified DDT across drug development programs.

The resources needed to develop a qualified DDT 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 collaborative efforts allow multiple interested parties to pool resources and data to decrease cost, expedite drug development, and facilitate regulatory review. Increased public availability of qualified DDTs for a specific context 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 is the manner and purpose of use for a DDT; when FDA qualifies a biomarker, it is qualified for a specific context of use.  The context of use statement should describe all of the elements characterizing this purpose and manner of use. The qualified context of use defines the boundaries within which the available data adequately justify use of the DDT. As data from additional studies are obtained over time, requestors of DDTs may continue working within the DDT qualification program to submit a new project with additional data to expand upon a 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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