FDA Expedited IND Pilot Program 2026: Final Design, Rolling Submission And First-in-Human Clinical Trial Guide

What the FDA’s 2026 Expedited IND Pilot Means for Drug Sponsors, Qualified Research Institutions and U.S. Clinical Development

The U.S. Food and Drug Administration (FDA) has finalized the design of its Expedited Investigational New Drug (IND) Pilot Program, introducing a collaborative and rolling-review approach intended to accelerate first-in-human (FIH) clinical trial initiation in the United States.

On 15 September 2026, FDA announced the final design of the pilot and opened the application period for sponsors seeking participation. The agency will accept applications until 30 October 2026 and expects to select approximately 8–10 Sponsor–Qualified Research Institution (QRI) pairs for the initial cohort.

The pilot is being implemented under HHS Operation Trial Blazer and is intended to evaluate whether closer collaboration between drug sponsors, specialized research institutions and FDA can reduce unnecessary delays during early-stage drug development while maintaining FDA’s standards for participant safety and scientific oversight.

Importantly, the pilot does not eliminate FDA’s regulatory authority or the statutory IND review framework. Instead, it changes how certain IND components can be developed, discussed and submitted before the final IND package is submitted.

For pharmaceutical and biotechnology companies preparing Phase 1 programs, the initiative creates a new regulatory-development model that may affect IND strategy, nonclinical planning, CMC readiness, clinical development, regulatory interactions and trial-site activation.

What Is Changing?

The Expedited IND Pilot is designed to test a more collaborative approach to preparing an IND for a Phase 1 FIH clinical trial.

Under the pilot, drug sponsors partner with qualified research institutions that can provide expertise across areas including:

• Nonclinical development
• Pharmacology and toxicology
• Clinical development
• Chemistry, Manufacturing, and Controls (CMC)
• Regulatory strategy
• Clinical trial startup activities

The QRI may be an academic medical center, healthcare network, contract research organization, regulatory organization or another research institution with appropriate scientific expertise.

The central change is the ability to submit individual IND components on a rolling basis during the pre-IND development period rather than waiting until the entire package is assembled.

This allows FDA scientists to identify questions earlier and gives sponsors an opportunity to address issues while development is still underway.

The Existing IND Framework Remains

The pilot should not be interpreted as a replacement for the traditional IND pathway.

FDA retains full regulatory authority throughout the process, including responsibility for determining whether a clinical investigation may proceed and whether a clinical hold is necessary. Participation is voluntary and does not change FDA's applicable standards for IND review or clinical trial conduct.

The final 30-day IND review period also remains relevant.

Once the sponsor submits the final complete IND package, the formal 30-day IND review window begins. The rolling process therefore primarily changes activities occurring during the pre-IND development period rather than removing the formal IND review process.

How the Rolling Submission Model Works

The rolling submission model is one of the most important features of the pilot.

During the pre-IND period, sponsors and QRIs can organize IND development into discrete, self-contained components. These may address specific scientific and regulatory areas such as nonclinical data, CMC information or clinical development elements.

Rather than submitting an incomplete or fragmented package, each component should be sufficiently structured to allow FDA review and should clearly identify the questions or areas where the sponsor is seeking regulatory alignment.

FDA can then provide feedback while other aspects of the IND program continue to develop.

This approach may allow companies to identify deficiencies earlier rather than discovering significant issues only after the final IND submission.

Once all relevant components are complete and feedback has been incorporated, the sponsor submits the final IND package. Any outstanding components can be included at that stage.

The sponsor remains responsible for the completeness and accuracy of the IND submission throughout the pilot.

Role of Qualified Research Institutions

QRIs are central to the pilot.

The FDA expects participating in QRIs to provide multidisciplinary scientific expertise and meaningful support for IND development. Prospective QRIs are expected to have capabilities across nonclinical, CMC and clinical disciplines and should be able to support acceleration of Phase 1 FIH trial initiation.

A QRI does not necessarily need to possess every capability internally. FDA states that institutions may supplement their capabilities through external subject-matter experts or organizations where necessary.

QRIs may also have infrastructure or formal arrangements supporting clinical trial startup activities, including:

• Institutional Review Board review
• Site contracting
• Site readiness
• Clinical trial activation

This broader role reflects the FDA's recognition that IND review is only one component of the overall timeline from drug discovery to first patient enrollment.

Who Is the Pilot Intended For?

FDA has established characteristics it will consider when prioritizing sponsor applications.

Priority characteristics include programs where:

• The product candidate is novel
• The program falls under CDER, CBER or the Oncology Center of Excellence
• The IND is a commercial IND
• The program is intended for a Phase 1 FIH trial
• The investigational product has no existing clinical experience
• The FIH trial will be conducted in the United States
• Sufficient preliminary nonclinical data is available
• The development program can realistically progress toward IND submission

The pilot can include different modalities and technologies, but support is focused on the specific investigation product identified in the application rather than broadly covering an entire technology platform.

Sponsor and QRI Responsibilities

A successful pilot application requires coordination between the sponsor and prospective QRI.

Sponsors may continue working with other CROs, CDMOs and external experts during the pilot. However, each sponsor may apply with one designated QRI.

CMC and Nonclinical Readiness Remain Critical

Participation in an expedited model does not eliminate the need for scientifically appropriate IND-enabling work.

The FDA is specifically evaluating whether the pilot can encourage phase-appropriate development while avoiding unnecessary data generation or over-submission.

Sponsors should therefore assess the maturity of:

• Pharmacology studies
• Toxicology studies
• CMC development
• Manufacturing processes
• Analytical methods
• Drug substance and drug product information
• Stability data
• Clinical protocol
• Starting material and manufacturing controls
• Risk-based development strategy

The goal is not simply to submit faster. Sponsors must be sufficiently prepared to engage FDA with meaningful, scientifically justified information.

Clinical Trial Startup Can Proceed in Parallel

Another significant feature is the potential coordination of activities that traditionally occur around or after IND development.

FDA identifies activities such as IRB review, site contracting and clinical trial site activation as areas that may be coordinated alongside IND development and review where appropriate.

This means sponsors should consider clinical operational readiness as part of their early regulatory strategy.

A regulatory team preparing an IND may therefore need closer coordination with:

• Clinical operations
• Medical affairs
• CROs
• Investigators
• IRBs
• Clinical sites
• CMC teams
• Nonclinical teams

The objective is to reduce unnecessary sequential steps where activities can appropriately proceed in parallel.

2026 Expedited IND Pilot Readiness Checklist

Application Process and Key Dates

FDA opened the Expedited IND Pilot application window on 15 September 2026.

The application requires information from both the sponsor and prospective QRI. FDA's application instructions identify two forms: a Sponsor and Investigational New Drug Information Form and a Prospective Research Institution Qualifications Form. The sponsor submits the application package through the FDA ESG Gateway.

The application period is scheduled to remain open until 30 October 2026. FDA expects to select the initial cohort by 18 December 2026, although timelines may vary depending on the number of applications received.

What This Means for Drug and Biotech Companies

The pilot is particularly relevant to companies that are:

• Preparing a novel drug for first-in-human development
• Building a Phase 1 IND strategy
• Developing U.S.-based clinical programs
• Evaluating regulatory support for IND preparation
• Seeking earlier FDA interaction during IND development
• Coordinating CMC, nonclinical and clinical activities
• Preparing for U.S. clinical site activation

Companies considering participation should assess whether their program is sufficiently advanced for meaningful QRI involvement but still early enough for expert input to influence development and submission strategy.

FDA specifically notes that the CMC and nonclinical programs should be sufficiently advanced to make an IND submission credible within a reasonable timeframe, while remaining early enough for QRI involvement to provide substantive value.

Frequently Asked Questions

1. Does the Expedited IND Pilot eliminate the IND process?

No. The pilot tests a different development and submission approach while retaining FDA's regulatory authority and the formal IND framework.

2. What is the main difference from the traditional process?

The pilot allows individual IND components to be submitted and reviewed on a rolling basis during the pre-IND period.

3. Does the 30-day IND review disappear?

No. The final complete IND submission starts with the applicable 30-day review period.

4. Who can participate?

The program is structured around a drug sponsor and prospective QRI applying together for a specific IND program.

5. Can sponsors continue using CROs and other consultants?

Yes. FDA states that sponsors may continue engaging other external experts, including CROs and CDMOs, while participating in the pilot.

6. What is the application deadline?

FDA's current deadline for sponsor applications is 11:59 p.m. ET on 30 October 2026.

Conclusion

The FDA's Expedited Investigational New Drug Pilot Program introduces a new approach to early-stage clinical development by bringing drug sponsors and qualified research institutions into a more coordinated IND-development model.

The program's key innovation is the rolling submission and review of IND components during the pre-IND period, combined with earlier identification of scientific and regulatory issues and potential coordination of clinical trial startup activities.

The pilot does not reduce FDA's authority or eliminate the formal IND review process. Instead, it is designed to test whether earlier scientific engagement, multidisciplinary QRI expertise and better coordination can make the path to first-in-human clinical trials more efficient while maintaining FDA's standards for participant safety and scientific oversight.

For drug sponsors considering participation, the immediate priority should be to evaluate program eligibility, nonclinical and CMC readiness, Phase 1 strategy, QRI suitability, rolling submission opportunities and clinical-site readiness before the 30 October 2026 application deadline.

As the pilot progresses, its results may also provide evidence for future FDA approaches to supporting and modernizing early-stage clinical development.

How Maven Regulatory Solutions Can Help

Maven Regulatory Solutions can support pharmaceutical and biotechnology companies with:

• Expedited IND Pilot eligibility assessments
• U.S. IND regulatory strategy
• First-in-human clinical development planning
• IND dossier readiness assessments
• Nonclinical and CMC regulatory gap assessments
• Phase 1 IND preparation
• QRI selection and regulatory coordination
• Rolling IND submission planning
• Clinical protocol and regulatory strategy
• FDA meeting and interaction preparation
• Clinical trial startup readiness
• Regulatory documentation review
• U.S. market-entry and clinical development strategy
• Regulatory intelligence and monitoring

Our approach helps sponsors prepare for evolving FDA early-stage development requirements while maintaining a structured, science-based strategy for U.S. clinical development.