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  1. Drug Development Tool (DDT) Qualification Programs

Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program

Spotlight Events & Announcements

CDER Statement: “FDA's ISTAND Pilot Program accepts submission of first artificial intelligence-based and digital health technology for neuroscience” (1/23/2024)

FDA published a new paper entitled, “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together” (3/15/2024), which outlines specific focus areas regarding the development and use of AI across the medical product lifecycle.

Get Started with Your Submission

The Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program accepts submissions for qualification of types of drug development tools (DDTs) that are out of scope for existing DDT qualification programs but may still be beneficial for drug development.

DDTs are methods, materials, or measures that have the potential to facilitate drug development. As described in the 21st Century Cures legislation, DDTs include biomarkers, clinical outcome assessments, and other methods, materials, or measures that aid drug development and regulatory review. To support DDT development efforts, FDA has established qualification programs for biomarkers, clinical outcome assessments, and for animal models for use under the Animal Rule. The ISTAND Pilot was established to cover other types of DDTs.

Examples of submissions that might be considered for ISTAND include, but are not limited to:

Tools that may help enable remote or decentralized trials

  • Application of patient-performed digital photography in dermatology trials

​Tools that may advance our understanding of drugs

  • Use of tissue chips (i.e., microphysiological systems) to assess safety or efficacy questions
  • Development of novel nonclinical pharmacology/toxicology assays

Tools that leverage digital health technologies

  • Use of artificial intelligence (AI)-based algorithms to evaluate patients, develop novel endpoints, or inform study design
  • Use of novel digital health technologies (e.g., wearables) for patient assessment

What outcomes are available under the ISTAND Pilot Program?

ISTAND’s goal is to support the development of novel approaches to drug development that may be acceptable for regulatory use. Some novel programs may be considered as DDTs eligible for qualification independent of a specific drug program and will go through the qualification process.

  • A qualified DDT can be relied upon to have a specific interpretation and application in drug development and regulatory review within its stated context of use. Once qualified, DDTs will be available to use in any drug development program for the qualified context of use. Additionally, the qualified DDT can generally be included in IND, NDA, or BLA applications without needing FDA to reconsider and reconfirm its suitability.
ISTAND Pathways Process Flow Chart: ISTAND (Submission or Referral) to 3 step Qualification Process to Qualified DDT or ISTAND (Submission or Referral) to ISTAND Continuous Engagement to Public Meeting, White Paper, Guidance

What information about submissions will be made public?

Submissions to the ISTAND Pilot Program that are admitted for review and deemed appropriate for qualification are subject to the transparency provisions of the 21st Century Cures Act. More information on these provisions can be found on the Drug Development Tool Qualification Process: Transparency Provisions webpage.

To locate a project or a qualified Drug Development Tool, go to CDER & CBER’s DDT Qualification Project Search database.

What is the nature of the pilot?

In the pilot phase, FDA anticipates accepting 2-4 submissions into the ISTAND program each year with a triage and selection process that focuses on public health impact and feasibility of implementation.

Information about grant opportunities:

The Drug Development Tools (DDT) Research Grant Cycle for Fiscal Years (FY) 2024 is now open. The FY 2024 DDT Grant Cycle is accepting applications through May 13, 2024 and FY 2025 through May 13, 2025. For additional information on how to apply for a DDT Research Grant, go to the “Drug Development Tools Research Grants (U01) Clinical Trial Optional" announcement available here: https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-24-030.html. If you have any questions regarding DDT Research Grants, please email CDER-DDTGrantsContracts@fda.hhs.gov.

For information on how to apply, see ISTAND Pilot Program Submission Process.


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