The U.S. Food and Drug Administration today announced the final design of the Expedited Investigational New Drug (IND) Pilot. Accelerating clinical trial timelines and eliminating regulatory hurdles to maintain American leadership in global medical innovation is a core priority for the Trump Administration. Driven by the President’s directive, the pilot seeks to accelerate the time it takes from identifying a drug to initiating a first-in-human clinical trial by partnering drug companies with qualified research institutions (QRI) that have scientific expertise to support efficient development of IND applications. The FDA will accept applications to participate in the pilot until October 30, 2026.
Currently, first-in-human clinical trials may take up to two years to complete in the United States. The same types of trials are completed much faster in China and Australia, threatening America’s leadership in scientific innovation. As a key component of the Trump Administration’s healthcare modernization efforts and as part of the U.S. Department of Health and Human Services’ Operation TrialBlazer, the FDA has committed to proactively addressing these clinical development challenges through dedicated initiatives such as the Expedited IND Pilot.
“The pilot not only pairs industry innovators with top research institutions to accelerate high-quality data being submitted to the FDA, it also tests if the partnership can accelerate what happens after the FDA allows a clinical trial to proceed,” said Acting FDA Commissioner Kyle Diamantas, J.D. “Under the Trump Administration, boosting domestic innovation and ensuring American patients have first access to groundbreaking treatments is a top priority. The FDA will continue implementing Operation TrialBlazer to modernize regulatory processes to keep our country ahead of global competitors without compromising patient safety.”
First-in-human trials are essential to determine proper dosing, absorption, and other key factors for potential approval of the drug in humans.
“The pilot hopes to utilize the American innovation ecosystem to accelerate the time to first-in-human clinical trials,” said Karim Mikhail, B. Pharm., M.S., Director of the Center for Biologics Evaluation and Research (CBER). “The FDA is doing our part to ensure American patients continue to receive access to therapies first, while keeping scientific innovation and investment in America.”
The QRIs selected for the pilot will bring specialized and substantial scientific expertise to the IND application preparation process allowing the FDA to review and accept individual components on a rolling review during the pre-IND phase, rather than waiting for all components to begin review. The pilot will help test whether this allows issues with an IND application to be identified and resolved in real time sooner — thereby reducing the risk of the FDA placing the first-in-human clinical trial protocol on hold (i.e., may not proceed) during the 30-day IND, and making the path from scientific discovery to first-in-human trial faster, more predictable, and more collaborative.
Ultimately, the pilot will generate evidence to inform potential future approaches to modernizing FDA’s support for early-stage clinical development. For example, this pilot may inform future policy initiatives which may result in a formal accreditation model that would recognize QRIs demonstrating strong scientific and regulatory judgment, aimed at creating a sustainable, high-quality network of institutions to support drug development and accelerate the time to first-in-human trials for drug sponsors.
The pilot also encourages coordination of activities that may occur alongside IND development and review, such as Institutional Review Board review and clinical trial site activation, where appropriate. By supporting earlier planning and more coordinated development activities, the pilot aims to reduce unnecessary delays between the point at which a drug sponsor begins preparing for an IND submission and the start of first-in-human studies.
The FDA retains full regulatory authority throughout the program, including responsibility for determining whether a clinical investigation may proceed, whether a clinical hold should be imposed, and all other regulatory oversight.
“The FDA greatly appreciates the public feedback we received on the proposed pilot, and we have incorporated that feedback into the final pilot design,” said Michael Davis, M.D., Ph.D., Director of the FDA’s Center for Drug Evaluation and Research (CDER). “The FDA is committed to ensuring the United States remains the global standard for pharmaceutical innovation and regulatory rigor for the benefit of American patients and innovators.”
The FDA’s Expedited IND Pilot webpage provides detailed information on program eligibility criteria, conflict of interest requirements, and the selection criteria the agency will use to determine participation. Drug sponsors and prospective QRIs will apply as a pair with drug sponsors submitting applications to the FDA.
The application period will be open until October 30, 2026. Applications will undergo review by FDA scientific experts. FDA expects that 8–10 Sponsor-QRI pairs will be selected to participate in the initial pilot cohort.
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