FDA launches pilot program to expedite early drug research and human trials

The U.S. Food and Drug Administration launched the Expedited Investigational New Drug Pilot program on September 15, 2026, to accelerate early-stage clinical trials. Part of the broader Operation TrialBlazer initiative, the program aims to counter the shift of drug testing to China and Australia, where regulatory processes are faster. By pairing drug sponsors with qualified research institutions and conducting rolling reviews, the FDA seeks to reduce U.S. trial preparation bottlenecks.

FDA expedited IND pilot program

• ▪The Food and Drug Administration's Expedited Investigational New Drug Pilot program is accepting applications from eligible drug sponsors, including smaller companies and startups, until October 30, 2026
• ▪The Food and Drug Administration aims to select eight to ten pairings of drug sponsors and qualified research institutions for the Expedited Investigational New Drug Pilot program, launched by the FDA on September 15, 2026
• ▪The U.S. Food and Drug Administration formally launched the Expedited Investigational New Drug Pilot program on September 15, 2026, to accelerate early clinical trials for new medicines

US-China-Australia clinical trial competition

• ▪Since the beginning of 2025, U.S. and European biopharmaceutical companies have signed more than 100 licensing deals with Chinese-based drug developers
• ▪Moving a drug into clinical trials in the United States typically takes up to two years, whereas the process can be several months shorter in China and Australia
• ▪Clinical trials run in China increased from under 1,000 annually in 2010 to more than 5,000 in 2024, while the rate in the United States remained stagnant at approximately 3,500 per year
• ▪In Australia, clinical trials can begin less than 70 days after a study protocol is submitted due to financial incentives and streamlined reviews

Rolling review process

• ▪The Food and Drug Administration's rolling review process under the Expedited Investigational New Drug Pilot program, launched September 15, 2026, is designed to identify and resolve issues early, reduce the risk of clinical holds, and make the path to human trials faster
• ▪Under the Expedited Investigational New Drug Pilot program, launched by the FDA on September 15, 2026, the Food and Drug Administration will conduct rolling reviews of application components as they are submitted, rather than waiting for a full submission
• ▪The Biotechnology Innovation Organization expressed skepticism that single research institutions could meet the Food and Drug Administration's requirements under the Expedited Investigational New Drug Pilot program and warned that the evaluations of qualified research institutions under that program might add an extra layer of review

Research institution partnerships

• ▪The Food and Drug Administration stated that the Expedited Investigational New Drug Pilot program, launched on September 15, 2026, could inform future efforts to establish a formal accreditation model for research institutions
• ▪The Food and Drug Administration will select up to 10 qualified research institutions, which can include academic research centers and contract research organizations, to partner with drug companies

Operation TrialBlazer initiative

• ▪Operation TrialBlazer was established to counteract moves by drugmakers to run clinical studies in countries like China and Australia that have faster regulatory environments
• ▪The Expedited Investigational New Drug Pilot program is part of Operation TrialBlazer, a Department of Health and Human Services initiative first announced in June 2026 to restore American leadership in clinical trials

Debatable claims

• ▪Offshoring clinical trials to China threatens US biotechnology leadership
• ▪The FDA's Expedited IND Pilot will speed up early drug trials