Expedited IND Pilot Program Educational Webinar for Stakeholders August 6, 2026

Webcast | Virtual

• Date: August 6, 2026
• Time: 9:00 a.m. - 10:00 a.m. ET

Background

The Food and Drug Administration is announcing an educational webinar on a proposal to establish the Expedited Investigational New Drug (IND) pilot program, a new program meant to  accelerate the time from drug identification to first-in-human (FIH) clinical trial. The potential pilot program which would establish a network of qualified research institutions, such as academic medical centers (AMCs), healthcare networks (HNs), contract research organizations (CROs), regulatory advisors, and/or other research or third-party review organizations (collectively called Qualified Research Institutions, or “QRIs”), who would partner with sponsors to develop and review protocols for FIH clinical trials intended for a IND submission to FDA. FDA is holding this webinar to clarify the intent behind the program, the purpose of the RFI, and answer specific stakeholder questions that might influence your feedback on the RFI.

Submit Comments

Comments on the Expedited Investigational New Drug Pilot Program must be submitted on or before 11:59 p.m. Eastern Time at the end of August 24, 2026. 

Submit electronic comments on https://www.regulations.gov to docket FDA-2026-N-4699.

Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date. 

For additional information, see Federal Register :: Expedited Investigational New Drug Pilot Program; Request for Information; Extension of the Comment Period. 

Registration

To attend the August 6, 2026 webinar, please complete the registration process below. Registration will remain open until the webinar begins, unless maximum capacity is reached earlier. 

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