Webcast | Virtual
Event Title
Expedited IND Pilot Program Educational Webinar for Stakeholders
August 6, 2026
- 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.
Webinar Agenda
- Welcome & Opening Remarks
Grace Graham, Deputy Commissioner for Policy, Legislation, and International Affairs - Program Overview
Ben Cook, MBA, Senior Advisor, Office of the Commissioner - Early Clinical Development Initiatives
Michael Davis, M.D., Ph.D., Acting Director, Center for Drug Evaluation and Research - Expedited IND Pilot Purpose and Structure
Karim Mikhail, B.Pharm, MSc, Acting Director, Center for Biologics Evaluation and Research
Mary Thahn Hai, M.D., Director of the Office of New Drugs, Center for Drug Evaluation and Research - Questions & Answers
Ben Cook, MBA, Senior Advisor, Office of the Commissioner - Closing Remarks
Karim Mikhail, B.Pharm, MSc, Acting Director, Center for Biologics Evaluation and Research
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.