The U.S. Food and Drug Administration (FDA) has outlined a new approach to modernizing the Investigational New Drug (IND) application process, with the goal of reducing delays in first-in-human Phase 1 clinical development in the United States.
In an FDA Voices article published on August 5, 2026, Karim Mikhail, B. Pharm, MSc, Acting Director of the FDA’s Center for Biologics Evaluation and Research, described growing concerns that the United States is losing ground in early clinical development.
According to the FDA, Phase 1 trials that may require up to two years to complete in the United States can be completed in approximately nine months in China. The agency warned that slower and less predictable development timelines could affect patient access to investigational therapies, regulatory oversight, scientific investment, employment, and intellectual property development within the United States.
In response, the FDA is planning an Expedited IND Pilot designed to clarify Phase 1 requirements, introduce specialized scientific partners into IND preparation, and allow components of an IND submission to be reviewed on a rolling basis.
Why the Existing Pre-IND Process Is Under Pressure
The FDA stated that the current pre-IND process was developed during a less complex period of drug development. The growing number and diversity of investigational products, particularly cell and gene therapies and other novel modalities, have placed increasing pressure on the existing framework.
One challenge is the lack of guidance written specifically for first-in-human Phase 1 trials. According to the agency, uncertainty about what information is required can lead sponsors to submit more data than necessary because of concerns that an incomplete application could result in a clinical hold.
The FDA believes that clearer, phase-appropriate expectations could reduce unnecessary submissions while maintaining patient safety.
The current process also generally provides sponsors with one pre-IND advisory meeting to address nonclinical, clinical, and Chemistry, Manufacturing and Controls questions. For complex products, the FDA noted that one non-binding interaction may not provide sufficient opportunity to resolve all scientific and regulatory issues before submission.
Delays Continue Beyond IND Review
Regulatory review represents only one stage of clinical trial initiation.
Even after an IND is permitted to proceed, sponsors may encounter additional delays related to Institutional Review Board review, site contracting, patient enrollment, and clinical site activation.
The FDA described these barriers as structural rather than intentional failures. These post-IND bottlenecks are also being addressed through the U.S. Department of Health and Human Services’ Operation TrialBlazer.
The proposed Expedited IND Pilot is intended to address both the preparation of the IND submission and, potentially, the operational steps required to begin a clinical trial.
Clarifying Requirements for First-in-Human Trials
The first part of the FDA’s proposed approach involves clarifying what information is scientifically appropriate for first-in-human Phase 1 trials.
The agency stated that the objective is to prioritize patient safety while reducing the ambiguity that can lead sponsors to over-submit information.
The FDA characterized this effort as an ongoing commitment rather than a single regulatory revision. Requirements would continue to evolve as scientific understanding advances and new therapeutic modalities enter development.
Qualified Research Institutions as Scientific Partners
A central feature of the proposed pilot is the participation of Qualified Research Institutions.
These institutions could include academic medical centers, contract research organizations, and other organizations with substantial expertise in specific scientific or therapeutic areas.
Under the proposed model, a sponsor would partner with a prospective QRI possessing the expertise, capabilities, and regulatory experience required to support the development program. Sponsor-QRI pairs would then apply to participate through a forthcoming pilot application process.
The QRI would provide substantive, iterative, and discipline-specific guidance during IND preparation. It would also help validate IND components and supporting data before their submission to the FDA.
The agency intends to test whether this form of real-time scientific collaboration can resolve regulatory questions earlier, improve submission quality, accelerate FDA review, and shorten the time required to initiate a first-in-human trial without compromising patient safety.
Rolling Review Could Reshape IND Timelines
The proposed pilot would also allow the FDA to review and accept individual components of an IND application as they are completed, rather than requiring sponsors to wait until the full submission package is assembled.
The FDA described a sequence beginning with the nonclinical package, which generally provides the scientific rationale and safety basis for proceeding to human testing.
Chemistry, Manufacturing and Controls information would follow as product characterization and manufacturing data mature. Clinical protocols and safety information would typically be submitted later, informed by the available nonclinical and manufacturing evidence.
Under the current process, sponsors generally hold these components until the full IND application is ready. The rolling submission model would allow the sponsor and its QRI partner to submit the individual sections as they become available.
The FDA would provide feedback on each component as it arrives. However, the formal 30-day IND review period would begin only after the final component has been submitted.
According to the agency, earlier engagement could allow scientific questions, disagreements, and potential deficiencies to be identified and addressed before the complete IND package reaches formal review. This could reduce the likelihood of a clinical hold and make the path to first-in-human testing more predictable.
Extending the QRI Model to Trial Activation
The pilot will also examine whether QRIs can serve as operational partners after IND preparation.
A QRI with established relationships with Institutional Review Boards, or one that directly operates clinical trial sites, could potentially begin certain trial activation activities earlier.
IRB review could start during the IND preparation process, using the same scientific information that shaped the regulatory submission. Site contracting could also begin before the FDA’s formal review clock starts, while clinical site activation could proceed in parallel with other activities rather than waiting for each step to be completed sequentially.
The FDA stated that this broader role could allow the QRI model to accelerate not only the quality and preparation of the IND submission but also the operational steps following the agency’s regulatory decision.
FDA Seeks Stakeholder Feedback on Pilot Design
The FDA has released a Request for Information to gather feedback from sponsors, research institutions, patients, and other stakeholders.
The agency stated that the proposed structure remains open to discussion. Areas for feedback include how relationships among sponsors, QRIs, and the FDA should operate; which research capabilities should be required; how IND components should be organized; and how the pilot’s success should be measured across different therapeutic areas and product modalities.
On August 6, 2026, the FDA is holding an Expedited IND Pilot Program Educational Webinar for Stakeholders. The webinar is intended to clarify the purpose of the program and its Request for Information, as well as address stakeholder questions that could inform formal responses.
A Broader Effort to Restore U.S. Clinical Trial Competitiveness
The FDA presented the Expedited IND Pilot as part of a wider effort to strengthen early clinical development in the United States.
The agency stated that delays in domestic Phase 1 development can limit access to investigational therapies for U.S. patients and reduce the FDA’s opportunity to influence scientific standards and oversee safety when trials move to other countries.
Slower timelines can also affect investment decisions, potentially shifting early-stage capital, scientific employment, and intellectual property development outside the United States.
By clarifying Phase 1 requirements, introducing QRIs as scientific partners, permitting rolling review, and allowing certain trial activation activities to occur in parallel, the FDA aims to create a faster, more collaborative, and more predictable path from scientific discovery to first-in-human clinical testing.
The agency emphasized that the proposed changes are intended to accelerate development without reducing regulatory standards or compromising patient safety.
Written by Nare Hovhannisyan, MD
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