FDA has launched a pilot program to expedite review of investigational new drug (IND) filings with applications for the pilot due by October 30. It is part of the agency’s Operation TrialBlazer initiative, designed to make the US more competitive in early-stage research.

By Patricia Van Arnum, Editorial Director, DCAT, [email protected]

Expediting IND reviews
The US Food and Drug Administration has announced the final design of the Expedited Investigational New Drug (IND) Pilot, which 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. FDA will accept applications to participate in the pilot until October 30, 2026.

Currently, FDA estimates that first-in-human clinical trials may take up to two years to complete in the US compared to shorter times in other countries, including China and Australia. The pilot is a key component of the Administration’s healthcare modernization efforts and specifically is part of the US Department of Health and Human Services’ (HHS) Operation TrialBlazer initiative. FDA believes sponsors may save up to 6 to 12 months of development time versus current IND submissions with the expedited program.

“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, in a September 15, 2026, statement. “…The FDA will continue implementing Operation TrialBlazer to modernize regulatory processes to keep our country ahead of global competitors without compromising patient safety.”

The Administration’s policy initiatives in early-stage drug research centers on expanding its oversight of clinical trials overseas as well as shortening the time it takes from drug identification to first-in-human Phase 1 clinical trials. These actions reflect the interest of the US to strengthen domestic R&D and increase clinical trial activity to address the rising role of ex-US R&D, particularly in China. The numbers tell the story of the increased role of China in R&D. In 2021, China’s global share of Phase I trials surpassed the United States’ share for the first time. In 2024, China surpassed the United States in the total number of clinical trials registered, with over 7,100 registered, representing 39% of global trials, according to information from HHS.

China’s ascent as a major R&D player is reflected in the increased domestic trial activity and increased deal-making with international companies. Trial starts from China-headquartered sponsors have mainly been driven by domestic-only trials, referring to those that were exclusively conducted in China, which account for between 75% and 88% of China-headquartered sponsor trials, according to a recent analysis by the IQVIA Institute of Human Data Science. This high level of domestic trial activity has also resulted in China becoming a top location globally for industry-sponsored single-country trials by Emerging Bio/pharma companies. In addition, licensing deals and mergers and acquisitions (M&A) between China-headquartered bio/pharma companies and international companies overall surged to an all-time high in 2025, with almost half of these deals involving a US partner, according to the IQVIA Institute analysis. The overall number of international deals for China-based companies surged in 2025, with 94 M&A or licensing deals, up from 71 in 2024, and with the largest increase from North American companies, predominately the US, followed by European companies.

Expedited IND Pilot
The QRIs selected for the Expedited IND Pilot will bring specialized and 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 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.

FDA says 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’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 FDA.

The application period will be open until October 30, 2026. Applications will undergo review by FDA scientific experts. FDA expects that eight to ten Sponsor-QRI pairs will be selected to participate in the initial pilot cohort.