FDA's Expedited IND Pilot Program: Could This Transform the Path to First-in-Human Studies?

What is FDA's Expedited Investigational New Drug (IND) Pilot Program?

The U.S. Food and Drug Administration (FDA) announced at the beginning of August 2026, that it is exploring a new Expedited Investigational New Drug (IND) Pilot Program designed to accelerate the path from candidate selection to first-in-human (FIH) studies while maintaining regulatory standards for patient safety and scientific rigor. The proposal introduces earlier scientific engagement, potential rolling IND submissions, and collaboration with Qualified Research Institutions (QRIs) to improve submission quality and reduce avoidable delays^1,2.

The agency is exploring a model that would allow IND components to be submitted and reviewed incrementally rather than waiting for a complete package. If implemented, this could create a more flexible development pathway and facilitate earlier feedback.

For sponsors, this is more than an administrative update, it forms part of FDA's broader effort to accelerate and modernize clinical development in the United States³.

Why is the FDA proposing this change?

The FDA has stated that the United States is losing ground in early clinical development, noting that Phase 1 studies that can take up to two years to complete in the U.S. may be completed in as little as nine months in China. The agency has identified increasingly complex therapeutic modalities, including cell and gene therapies, as a key driver for modernizing the current pre-IND framework³.

A key objective of the pilot is reducing clinical holds by encouraging higher-quality submissions and addressing scientific questions before an IND package reaches FDA review².

"The most notable aspect of FDA's Expedited IND Pilot Program is that it goes beyond simply shortening review timelines. It seeks to redesign how sponsors, regulators, and development partners interact during the earliest stages of drug development. By emphasizing phase-appropriate requirements and proactive scientific collaboration, FDA is laying the groundwork for a more agile and innovation-friendly development ecosystem."

 - Alicia Baker McDowell, DRSc, MS, EMBA, Vice President, Head of Regulatory Consulting, Fortrea

What could this mean for sponsors?

Several proposed elements could significantly influence early development strategy:

• Earlier regulatory planning - Sponsors may need to engage regulatory strategists, protocol designers, and development teams earlier than traditional IND preparation timelines. Early alignment on development objectives, data requirements, and regulatory expectations could become increasingly important.
• New collaboration models - The proposed QRI framework places greater emphasis on external scientific and regulatory support. Academic institutions, CROs, regulatory consulting organizations, and healthcare networks could play a larger role in helping sponsors prepare Phase 1 submissions^1,2.
• Greater focus on phase-appropriate requirements - FDA has signalled interest in clarifying what information is required to support safe initiation of Phase 1 studies while reducing unnecessary data generation. This could help sponsors avoid activities that add cost and time without improving regulatory decision-making^1,2.

What actions should sponsors take now?

While the pilot remains under evaluation, sponsors can begin preparing for a more collaborative and proactive regulatory environment by:

• Reviewing current development plans for upcoming first in human (FIH) programs
• Assessing whether existing data packages support a phase-appropriate regulatory strategy
• Identifying potential regulatory risks that could result in review delays or clinical holds
• Evaluating opportunities for earlier scientific and regulatory engagement
• Building development plans that align regulatory expectations, clinical objectives, and commercial goals from the outset

As regulatory expectations continue to evolve, sponsors may benefit from taking a broader view of development planning. Fortrea integrates regulatory strategy, intelligence, and execution across the full asset lifecycle, helping sponsors make informed decisions earlier and design development programs that stand up to regulatory and commercial scrutiny. Through continuous regulatory intelligence, regional fluency, and thoughtful application of advanced technology, we help reduce risk, prevent re-work, and keep development on track from early planning through post-approval commitments.

Now is the time to review your program strategy. Engage Fortrea's Regulatory Strategy team to evaluate your project objectives, available data, and regulatory pathway options before critical development decisions are made.

FAQs

Q. What is FDA's Expedited IND Pilot Program? 
A. The proposed program is intended to accelerate the transition from drug identification to first-in-human clinical trials through earlier scientific collaboration, potential rolling IND submissions, and involvement of FDA-recognized Qualified Research Institutions^1,2.

Q. What are Qualified Research Institutions (QRIs)?
A. Qualified Research Institutions (QRIs) may include academic medical centers, healthcare networks, CROs, regulatory advisors, and other research organizations that would work with sponsors to develop and review Phase 1 protocols prior to IND submission.

Q. How could the Expedited IND Pilot Program affect sponsors? 
A. If implemented, the program could encourage earlier regulatory planning, more iterative interactions during IND preparation, improved submission quality, and reduced risk of clinical holds that delay first-in-human studies.

References

1. U.S. Food and Drug Administration. Expedited IND Pilot Program Educational Webinar for Stakeholders (August 6, 2026). https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/expedited-ind-pilot-program-educational-webinar-stakeholders-08062026. Last updated 6 August 2026. Last accessed 12 August 2026. 
2. U.S. Food and Drug Administration. FDA Actions to Accelerate and Modernize Early and Late-Stage Clinical Development. https://www.fda.gov/industry/fda-actions-accelerate-and-modernize-early-and-late-stage-clinical-development. Last updated 27 July 2026. Last accessed 12 August 2026.
3. U.S. Food and Drug Administration. America Must Address Early Clinical Development. August 5, 2026. https://content.govdelivery.com/accounts/USFDA/bulletins/423b68e. Last updated 5 August 2026. Last accessed 12 August 2026.