Expedited IND Rolling Submission Process and Program Structure

FDA has detailed how its Expedited IND Pilot will work, with most activity occurring during the pre-IND phase of nonclinical development before the official 30-day IND application. Sponsors submit discipline-specific components on a rolling basis through the ESG gateway to their pre-IND, with a Qualified Research Initiative (QRI) reviewing each component and flagging issues that could trigger a clinical hold. FDA will let sponsors and QRIs set the submission sequence and timeline, and sponsors plus QRIs will give written and verbal feedback throughout the pilot, from IND-initiating activities to first-in-human trial initiation, to shape future iterations.