On July 31, 2025, the U.S. Food and Drug Administration (FDA) announced that the Innovative Science and Technology Approaches for New Drugs (ISTAND) initiative is now a Permanent Qualification Program. This decision marks a turning point in how the agency evaluates and qualifies Drug Development Tools (DDTs), including New Approach Methodologies (NAMs) and other novel technologies such as organ-on-a-chip platforms and artificial intelligence models.
By making ISTAND permanent, the FDA has signaled that regulatory acceptance of NAMs and novel technologies is no longer hypothetical. It is becoming an expected part of the drug development ecosystem. For innovators, the opportunity to achieve qualification has never been greater, but so has the need for expertise in navigating this process.
Why You Need ISTAND and NAMs Consulting Expertise
Qualifying a tool under FDA’s ISTAND program requires more than good science. Submissions must demonstrate regulatory relevance, provide robust supporting data, and align with the agency’s evolving expectations. The process can be challenging without guidance from professionals who have direct experience with FDA ISTAND submissions.
Working with consultants experienced with ISTAND qualification can help drug developers:
- Design data packages tailored for regulatory acceptance
- Anticipate FDA questions and concerns early
- Strategically position their novel technologies for qualification
For companies with cutting-edge DDTs, the difference between success and costly delays often comes down to expert navigation of FDA’s processes.
How to Use NAMs Data in FDA IND, NDA, and BLA Submissions
Beyond tool qualification, drug developers must now consider how NAMs data fit into their regulatory submissions. The FDA has been clear through its Roadmap to Reducing Animal Testing in Preclinical Safety Studies that the agency is actively incentivizing the adoption of modern, human-relevant approaches where scientifically appropriate. This shift is not just a long-term aspiration. It is already shaping FDA expectations for INDs (Investigational New Drug applications), NDAs (New Drug Applications), and BLAs (Biologics License Applications).
By aligning with the FDA’s roadmap and incorporating NAMs data, companies can:
- Reduce or replace animal testing in line with FDA policy direction
- Strengthen regulatory credibility by demonstrating proactive adoption of innovative science
- Accelerate timelines by relying on faster, more predictive technologies
- Differentiate themselves competitively by being early adopters of regulatory-endorsed methods
The FDA is increasingly treating NAMs as integral components of safety and efficacy arguments, not just supplemental information. Drug developers that embed NAMs into their submission strategies today will be ahead of the curve tomorrow, with stronger FDA interactions and a clearer path to approval.
InnovApproach: Unique Experience in FDA ISTAND Qualification
At InnovApproach Consulting, we provide something few others can: hands-on experience leading the very first technology submission ever accepted into FDA’s ISTAND program. Our founder, Michael Phelan, PhD, not only guided that submission to the ISTAND program, but also helped shape the program as it developed.
This means InnovApproach does not just know the ISTAND submission process. We have lived it. Our team helps clients:
- Qualify NAMs and novel Drug Development Tools through FDA ISTAND
- Integrate NAMs data effectively into IND, NDA, and BLA submissions
- Translate complex science into regulatory success
Learn more about our services here.
ISTAND is now permanent. NAMs are no longer the future, they are the present. If you are developing a novel technology that could transform drug development, now is the time to act. Contact InnovApproach Consulting today to accelerate FDA qualification and bring your innovations into the regulatory mainstream.
Interested in NAMs and the FDA ISTAND program? Learn more from our NAMs Resources page.
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