FDA to test new approach to expediting Phase 1 trials
The US Food and Drug Administration (FDA) announced on Tuesday the launch of a pilot program designed to expedite the review of early-phase clinical trials for investigational new drugs (INDs). This program introduces a rolling submission process that pairs sponsors with qualified research institutions.
The agency is now accepting applications for participation in this program.
The Expedited IND pilot is part of the Operation Trialblazer Program, announced by the Department of Health and Human Services (HHS) and FDA in June. The initiative features several measures designed to speed up drug development from the IND stage to late-stage clinical trials. (RELATED: HHS and FDA propose clinical trial reforms to expedite drug development, Regulatory Focus 23 June 2026)
Under the pilot program, pharmaceutical companies will work with qualified research institutions, such as academic medical centers or contract research organizations, to develop Phase 1 Investigational New Drug (IND) submissions for first-in-human (FIH) clinical trials. This collaboration will utilize a rolling IND submission platform, designed to reduce the chances of clinical holds.
This initiative is part of the Trump Administration's efforts to modernize healthcare and address the trend of offshoring clinical trials to other countries.
According to FDA, currently, it takes up to two years to complete first-in-human clinical trials in the US, while these trials are completed much faster in countries such as China and Australia.
“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,” acting FDA Commissioner Kyle Diamantas said.
Karim Mikhail, director of the Center for Biologics Evaluation and Research (CBER) said in a statement that “the pilot hopes to utilize the American innovation ecosystem to accelerate the time to first-in-human clinical trials. 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.”
FDA said the QRIs selected for the pilot are expected to bring “specialized and substantial scientific expertise” to the IND review process. This initiative will enable FDA to review and accept individual components of applications on a rolling review during the pre-IND phase, rather than waiting for all components to be submitted before starting the review.
The pilot study aims to determine whether this approach enables real-time identification and resolution of scientific issues related to IND applications and reduce the risk of FDA putting the clinical trial on hold during the 30-day IND review period.
The agency also announced the launch of its Expedited IND Pilot webpage which includes information on eligibility criteria and conflict of interest requirements.
Drug sponsors and potential QRIs will submit applications together to the FDA.
FDA plans to select between eight and ten sponsor-QRI pairs for the pilot program. The agency is accepting applications for participation until 30 October 2026.
