FDA Launches Expedited IND Pilot Program to Accelerate Clinical Trials

Silver Spring, MD, Sept. 15, 2026 /CourierPR/ -- The U.S. Food and Drug Administration (FDA) has launched an expedited Investigational New Drug (IND) pilot program aimed at accelerating the timeline for first-in-human clinical trials. This initiative, driven by the Trump Administration, seeks to reduce the time from identifying a drug to initiating a first-in-human clinical trial by partnering drug companies with qualified research institutions (QRIs) that possess the necessary scientific expertise.

According to Acting FDA Commissioner Kyle Diamantas, the pilot program is part of the administration’s broader effort to maintain American leadership in global medical innovation.

The pilot program will accept applications from drug companies and QRIs until October 30, 2026. The FDA will review applications to select 8 to 10 Sponsor-QRI pairs for the initial pilot cohort. The program aims to streamline the IND application process, allowing the FDA to review individual components on a rolling basis during the pre-IND phase. This approach is intended to identify and resolve issues in real time, reducing the risk of clinical trials being placed on hold.

Karim Mikhail, B. Pharm., M.S., Director of the Center for Biologics Evaluation and Research (CBER), explained that the pilot will test whether this partnership can accelerate the entire process from scientific discovery to first-in-human trials.

First-in-human trials are crucial for determining proper dosing, absorption, and other key factors necessary for potential approval of a drug in humans. The current timeline for these trials in the United States can take up to two years, significantly longer than in countries like China and Australia. This disparity threatens America’s leadership in scientific innovation.

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 program is part of the U.S. Department of Health and Human Services’ Operation TrialBlazer, which aims to modernize regulatory processes. The FDA retains full regulatory authority throughout the program, including the power to determine whether a clinical investigation may proceed and whether a clinical hold should be imposed.

The FDA has already incorporated public feedback into the final pilot design, ensuring that the program aligns with industry needs and expectations.

The pilot program is expected to generate evidence to inform potential future approaches to modernizing FDA’s support for early-stage clinical development. This could lead to a formal accreditation model that recognizes QRIs demonstrating strong scientific and regulatory judgment, creating a sustainable, high-quality network of institutions to support drug development and accelerate the time to first-in-human trials for drug sponsors.