Expedited IND Rolling Submission Process and Program Structure
Program Overview | Rolling Submission Process & Structure | Application Instructions
A majority of the Expedited IND Pilot will take place during the “Pre-IND” phase – the period of nonclinical development before the sponsor submits their official 30-day IND application.
During the pilot, the sponsor will continue to be responsible for submitting information to the FDA through the ESG gateway, and will maintain accountability for the completeness of their IND package. Sponsors may choose to have prospective QRIs act as authorized representatives via Form 1571, allowing them to submit to the FDA on the sponsor’s behalf, but it will not be required during the pilot.
Rolling IND Submission
Sponsors will be asked to submit discipline specific components to their PIND on a rolling basis. Before any component is submitted to their PIND, the QRI is expected to have determined if the submission incorporates scientifically sound rationale and data, and provided the sponsor with clear, actionable feedback if necessary, distinguishing between issues that must be addressed to avoid a clinical hold and those that represent opportunities for further strengthening the application. This means sponsors should view the QRI as an accountable scientific partner whose endorsement of the submissions is a meaningful checkpoint in the pre-IND process.
Sponsors may submit discipline specific IND components through the ESG gateway to their PIND for FDA review. FDA will ask sponsors to submit a proposed timeline for rolling IND submission. Rather than prescribing a specific submission order, FDA will allow the sequence to be determined by the sponsor’s development program and the guidance of the QRI. This approach is intended to best advance alignment between FDA and sponsors while accelerating the path to IND submission. At a high level, PIND discipline-specific component submissions should be framed by the sponsor/QRI as a discrete, self-contained package, not a partial or fragmentary data drop, with a clear statement of what questions and perspective the sponsor is seeking alignment. Additional guidance as to what constitutes an IND component and expected timelines will be provided to pilot participants.
Once all components are complete and all prior feedback has been incorporated, the sponsor will submit the final IND. Sponsors are not required to submit every remaining component through the rolling Pre-IND process if doing so would delay the final IND submission; any outstanding components may be submitted directly under the final IND submission. This final IND submission, which should include all outstanding components not previously submitted under the rolling process, will constitute the complete IND package and signal the start of the 30-day IND review window. Before this final submission, the sponsor and QRI should conduct a final comprehensive evaluation of the IND package, ensuring completion and conformance with applicable regulatory standards.
Program Evaluation and Tracking
Sponsors and QRIs will be asked to provide both written and verbal feedback throughout the pilot from IND-initiating activities until FIH trial initiation, including on the overall process, lessons learned, and the specific role the QRI played at each stage, such as whether the QRI was involved solely in evaluating a completed IND component, or partnering with the sponsor in its development. This feedback will allow FDA to make timely improvements and inform future iterations of the program.
FDA's vision for the QRI is that of a trusted scientific partner. The QRI should bring expertise and clarity to the IND development process, helping sponsors conduct the right studies to meet regulatory standards without introducing unnecessary burden or delay. Therefore, FDA does not intend to enforce strict timelines or requirements for QRI interactions with sponsors regarding IND components, or partnership models between QRIs and sponsors. Instead, FDA hopes to allow industry to find the most productive ways for sponsors and research institutions to collaborate during the pilot with the shared goal of accelerating drug development and reducing the time to first-in-human trials.