How FDA’s ISTAND Initiative Supports Innovative Tools in Drug Discovery and Development

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FDA’s Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program, launched in November 2020 as a pathway to qualify novel drug development tools (DDTs) not fitting within existing agency qualification parameters, is transitioning to a permanent DDT qualification program, according to an FDA Voices blog post published July 31, 2025 by ShaAvhrée Buckman-Garner, MD, PhD, director of the Office of Translational Services at FDA’s Center for Drug Evaluation and Research (CDER), and Mary Thanh Hai, MD, acting director of CDER’s Office of New Drugs (1,2).

DDTs defined

FDA defines DDTs as “methods, materials, or measures” with the potential to facilitate drug development, counting among them tools that may: help to enable remote or decentralized trials (e.g., patient-performed digital photography in dermatology trials), advance understanding of drugs (using tissue chips to assess safety or efficacy, or developing novel, nonclinical pharmacology or toxicology assays), or leverage digital health technologies—such as artificial intelligence (AI)-based algorithms or wearables used for patient assessment (2).

DDTs evaluated to be “qualified” have a proven, specific use, and can be incorporated into any drug development program for a particular purpose (1). FDA maintains a database of DDT qualification projects under the umbrella of both CDER and the Center for Biologics Evaluation and Research.

ISTAND’s record so far

ISTAND is being transitioned to a permanent program based on a total of eight accepted submissions over its nearly five-year pilot phase: three AI-based tools, two animal-free tools to assess preclinical safety, two novel methods involving tissues, and a novel statistical approach (1). Some examples of advanced tools the program has helped facilitate the integration of include organ-on-a-chip models, digital health technologies like fitness trackers, and complex in-vitro models.

As FDA continues to provide feedback on the submissions that have been accepted, the transition of ISTAND to a permanent program has numerous potential effects on drug developers and manufacturers.

Drug discovery and development

For those involved in early-stage drug discovery, ISTAND’s permanency offers a clearer regulatory pathway for leveraging unconventional tools to generate and validate drug candidates. This includes, for example, the use of machine learning algorithms to identify promising compounds or targets, or the application of wearable devices to monitor real-world outcomes in preclinical and early clinical studies.

Drug development teams stand to benefit through more consistent engagement with FDA scientists, potentially reducing regulatory uncertainty associated with novel methodologies. This regulatory support may lead to greater investment in, and adoption of, innovative approaches to trial design, patient stratification, endpoint selection, and safety monitoring.

Drug manufacturing

While ISTAND is not directly focused on manufacturing processes, its emphasis on novel data collection and analysis techniques could influence manufacturing by fostering tools that enhance process monitoring, quality assurance, and continuous manufacturing. For instance, digital sensors that monitor physiochemical parameters during production, or AI models that optimize process controls, could eventually be submitted through ISTAND for qualification, if their intended use supports a regulatory decision related to a new drug application.

Collaboration and transparency

A key feature of the ISTAND program is its transparency and collaborative engagement with stakeholders. The qualification process involves public posting of DDT submissions, feedback from FDA reviewers, and potential publication of qualified tools for broader industry use. This not only facilitates innovation within individual sponsors’ programs but also accelerates collective learning across the sector.

The formal establishment of ISTAND reflects FDA’s evolving approach to supporting scientific innovation in drug development. By offering a defined path for the qualification of nontraditional tools, the program is expected to expand the toolkit available to researchers and developers, thereby enabling more efficient and patient-centric drug development.

References

1. Buckman-Garner, S. and Thanh Hai, M. FDA Advances Drug Development Innovation by Establishing ISTAND as Permanent Qualification Program. FDA Voices. FDA.gov, July 31, 2025 (accessed Aug. 4, 2025).
2. FDA. Innovative Science and Technology Approaches for New Drugs (ISTAND) Program. FDA.gov, last updated July 31, 2025 (accessed Aug. 4, 2025).