The US Food and Drug Administration is holding an educational webinar today, August 6, to discuss its proposed Expedited Investigational New Drug Pilot Program, an initiative designed to shorten the path from drug development to first-in-human clinical trials.
During the webinar, the FDA explained the purpose of the pilot and its Request for Information, answered stakeholder questions, and gathered feedback on how the programme should operate. Discussions are expected to address the relationship between sponsors, the FDA and Qualified Research Institutions, as well as submission structures, research capabilities and measures of success across different therapies.
On July 22, the US Food and Drug Administration proposed a new programme aimed at shortening the time it takes to move experimental treatments from the laboratory into first-in-human clinical trials.
The proposed Expedited Investigational New Drug Pilot Program would change how sponsors prepare Investigational New Drug applications. Instead of relying mainly on a single pre-IND meeting and submitting the full application at once, sponsors could receive ongoing support from Qualified Research Institutions and submit different parts of the application as they become ready.
These sections could include pharmacology and toxicology data, which provide evidence about the treatment’s activity and safety; Chemistry, Manufacturing and Controls information, which explains how the product is produced and tested; and the clinical protocol, which outlines the design, dosing and safety monitoring of the first-in-human trial. The FDA could review each section while the sponsor continues preparing the rest of the application.
FDA Highlights Delays in Early Development
Karim Mikhail, who’s currently heading the FDA’s Center for Biologics Evaluation and Research, didn’t mince words about the problem in a recent FDA Voices piece:
“Phase 1 trials that may take up to two years to complete here in the United States are completed in nine months in China.”
Part of the issue, according to the FDA, is that the current pre-IND process just doesn’t offer enough guidance for how complicated these newer therapies have gotten. That uncertainty pushes sponsors to over-prepare, submitting more data than they probably need to, just to avoid the risk of a clinical hold. And even once a sponsor clears that hurdle, there’s still ethics review, site contracts, and patient recruitment to get through before a trial actually starts.
US Health Secretary Robert F. Kennedy Jr., in a statement accompanying the pilot’s announcement, said:
“America should be the best place in the world to develop new medicines, yet we have built a system that drives too much clinical research overseas.”
So What Would Actually Change?
The pilot would pair sponsors with what the FDA is calling Qualified Research Institutions, or QRIs – think academic medical centers, hospital networks, contract research organizations, and regulatory consultants. Instead of building an entire IND application in isolation and submitting it as one big package, sponsors could hand over sections (nonclinical data, manufacturing details, clinical plans) as each is finished, and get FDA feedback along the way.
The hope is that this rolling review catches problems early, cuts down on clinical holds, and generally makes the road to a first-in-human trial less of a black box.
Still Just a Proposal
None of this is locked in yet. The FDA is currently collecting public feedback on how the pilot should be structured and how to measure whether it’s actually working. Comments are open through August 24, 2026.
If it does move forward, this could reshape how first-in-human studies get built and reviewed, but a lot depends on whether it can actually cut delays without cutting corners on safety and scientific rigor.
For a more detailed look at the proposal, read our full article:
FDA Proposes Expedited IND Pilot to Accelerate Early Clinical Development in the United States
