FDA opens Expedited IND Pilot to speed first-in-human US trials

The US Food and Drug Administration opened applications on 15 September 2026 for a pilot that pairs drug developers with research institutions to speed up the start of first-in-human trials. The Expedited Investigational New Drug (IND) Pilot lets the agency review parts of an IND application on a rolling basis before the full package is filed, with the aim of catching problems early and avoiding clinical holds.

The FDA said it expects to pick 8 to 10 sponsor and institution pairs for the first cohort. Applications closed on 30 October 2026.

The pilot is part of Operation TrialBlazer, a Department of Health and Human Services (HHS) effort to shorten US clinical development timelines.

Why the FDA says it is needed

In its announcement, the FDA said first-in-human trials "may take up to two years to complete in the United States," while the same types of trials "are completed much faster in China and Australia, threatening America's leadership in scientific innovation."

First-in-human trials are the first time a new medicine is given to people. They establish the starting dose, how the body absorbs and clears the drug, and early safety. Before one can start in the US, a sponsor must submit an IND. The FDA then has 30 days to review it, after which the trial may proceed unless the agency places it on clinical hold.

The pilot is aimed at the period before and around that 30-day window: the time it takes to assemble an IND, to resolve questions, and to get sites ready once the FDA allows the trial to go ahead.

How the pilot works

The central idea is a partnership between a drug sponsor and a qualified research institution (QRI). QRIs are institutions with scientific expertise in preparing IND applications.

Under the pilot:

• Sponsors and prospective QRIs apply as a pair, with the sponsor submitting the application to the FDA.
• The QRI contributes specialist scientific expertise while the IND is prepared.
• The FDA can review and accept individual components of the application on a rolling basis during the pre-IND phase, without waiting for the full application.
• The pilot encourages related steps, such as Institutional Review Board review and site activation, to run alongside IND preparation and review where appropriate.

The FDA said rolling review should help identify and resolve problems "in real time sooner," reducing the risk that it places the first-in-human protocol on hold during the 30-day IND review.

What the FDA keeps

The agency stressed that it "retains full regulatory authority throughout the program." That includes deciding whether a trial may proceed, whether to impose a clinical hold, and all other oversight. The QRI does not approve anything on the FDA's behalf.

Who said what

Acting FDA Commissioner Kyle Diamantas said the pilot "pairs industry innovators with top research institutions to accelerate high-quality data being submitted to the FDA." He added that it "also tests if the partnership can accelerate what happens after the FDA allows a clinical trial to proceed."

Karim Mikhail, director of the Center for Biologics Evaluation and Research, said it "hopes to utilize the American innovation ecosystem to accelerate the time to first-in-human clinical trials."

Michael Davis, director of the Center for Drug Evaluation and Research, said the FDA had received public feedback on the proposed pilot and had "incorporated that feedback into the final pilot design."

Selection and eligibility

The FDA's pilot webpage sets out eligibility criteria, conflict of interest requirements, and the selection criteria the agency will use. FDA scientific experts will review applications. The agency expects 8 to 10 pairs in the initial cohort.

The press release does not name any institutions or sponsors, and the FDA had not announced selected pairs at the time of writing.

A path towards accreditation

The pilot is framed as a test. The FDA said it will "generate evidence to inform potential future approaches" to supporting early-stage development. One option it names is a formal accreditation model that would recognise QRIs "demonstrating strong scientific and regulatory judgment," to build a network of institutions that support drug development and speed up first-in-human trials.

That would be a significant change. It would give accredited outside institutions a recognised role in preparing the applications the FDA reviews, while the agency keeps the decision.

Operation TrialBlazer

The FDA has published a page listing other actions under Operation TrialBlazer to modernise early and late-stage development. Alongside the Expedited IND Pilot, it lists:

• a new Phase 1 IND resources webpage that gathers IND requirements, guidance and practical examples in one place, which the FDA says is aimed partly at smaller companies without large regulatory teams
• an updated chemistry, manufacturing and controls (CMC) webpage for CDER-regulated drugs that spells out what data a first-in-human IND needs, which the FDA says could save companies 6 to 12 months of development time
• a Phase 1 Contact Center for questions on protocols and early-phase requirements, reachable at 240-276-9358 or Phase1Questions@fda.hhs.gov
• draft guidance on using quantitative systems pharmacology to select a first-in-human dose based on the minimum anticipated biological effect level, part of a move away from relying on animal toxicology studies to set that dose
• revised draft guidance on substantial evidence of effectiveness, clarifying when one adequate and well-controlled trial plus confirmatory evidence may support approval
• revised draft guidance on master protocols, which cover basket, umbrella and platform trials

From proposal to final design

The FDA first proposed the pilot when it announced its Operation TrialBlazer actions earlier in 2026, and asked for stakeholder feedback. Law firm Ropes & Gray, in a July 2026 client alert, described the proposal as a voluntary programme in which sponsors would work with third-party institutions on phase 1 IND submissions through a rolling submission platform, with the goal of improving submission quality and speeding authorisation to proceed.

The September announcement set out the final design. Davis said public feedback had been built into it. The FDA also ran an educational webinar on the programme and published a dedicated pilot webpage covering how applicants are prioritised, conflict of interest requirements and selection considerations.

The wider context

The pilot arrived two weeks after the FDA published "Good Clinical Practices Are Not Optional", an article by the heads of its main centres warning that data from foreign sites it cannot inspect may not support approval. That article highlighted early-phase and first-in-human trials run abroad as a particular concern. We cover it in our article on the FDA's warning about foreign trial data.

Read together, the two moves aim to make early trials in the US faster while tightening scrutiny of early trials run elsewhere.

Other regulators are competing on the same ground. The UK's MHRA is working towards a 14-day initial assessment for first-in-human trials as part of its Strategy 2030, which we report in our article on MHRA Strategy 2030. In the EU, the proposed Biotech Act would introduce faster authorisation for multinational trials, covered in our article on the Biotech Act and CTIS.

Questions the pilot will need to answer

Industry and academic observers will be watching several points as the pilot runs:

• Whether rolling pre-IND review actually shortens the overall time to first dosing, or mainly moves work earlier.
• How conflicts of interest are managed when a QRI works closely with a commercial sponsor.
• Whether smaller biotech companies, which often lack in-house regulatory teams, benefit most.
• How site activation and ethics review can be run in parallel without cutting corners.
• What resources the FDA needs to support rolling review at scale.

The FDA has said the pilot is meant to generate evidence for future policy. Results from the first cohort will shape whether an accreditation model follows.

What it means for patients

For patients, faster first-in-human trials could mean promising treatments reach later-stage trials, and eventually approval, sooner. The early trials themselves involve small numbers of people, often healthy volunteers or patients with advanced disease, and carry the most uncertainty. The FDA says patient safety remains its priority and that it keeps the final say on whether any trial goes ahead.

People considering a first-in-human trial should expect detailed consent discussions, close monitoring and frequent clinic visits. The pilot does not change the ethics review or consent requirements that apply to every US trial; it encourages ethics review to run alongside IND preparation where appropriate, so that a trial can start soon after the FDA allows it.

Our patient guide on how new medicines get approved explains the stages from first-in-human trial to approval.

What happens next

The application window closed on 30 October 2026. The FDA expects to select 8 to 10 sponsor and QRI pairs. It has not published a date for announcing them or for reporting results.

Related reading

• FDA warns it may reject foreign trial data it cannot verify
• How to find and join a clinical trial

This article is for general information and is not medical advice. Please talk to your own doctor before joining a trial or changing any treatment.