Federal Register #FDA-2026-N-4699

FDA Seeks Input on Expedited IND Pilot Program for First-in-Human Clinical Trials

The Food and Drug Administration (FDA), under the Department of Health and Human Services, is seeking stakeholder input on a proposed Expedited Investigational New Drug (IND) Pilot Program. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - Purpose: - Gather information and comments from stakeholders on the design and implementation of a pilot program to accelerate the timeline from drug identification to first-in-human (FIH) clinical trials - Program Details: - Establish a network of Qualified Research Institutions (QRIs), such as academic medical centers, healthcare networks, contract research organizations, and regulatory advisors - QRIs would partner with sponsors to develop and review protocols for FIH clinical trials intended for IND submission - Pilot aims to improve IND submission quality, reduce FDA review time through a rolling submission process, and speed up clinical trial initiation - FDA will retain full regulatory authority and oversight throughout the pilot - Products/Services Requested: - No specific products, OEMs, or purchase quantities are listed - Request is for information and input from qualified institutions and stakeholders - Unique Requirements: - Focus on innovative approaches to streamline IND submissions and clinical trial startup - Emphasis on maintaining participant safety while accelerating timelines - Collaboration with a diverse network of research and regulatory organizations

Description

The Food and Drug Administration (FDA) is soliciting input and comments on a proposal to establish a pilot program aimed at shortening the time from drug identification to first-in-human (FIH) study while protecting clinical trial participants. The pilot program would establish a network of qualified research institutions (QRIs) such as academic medical centers, healthcare networks, contract research organizations, and regulatory advisors to partner with sponsors in developing and reviewing protocols for FIH clinical trials intended for IND submission to FDA. The program aims to improve the quality of IND submissions, reduce FDA review time through a rolling submission process, and accelerate clinical trial initiation activities. FDA will retain full regulatory authority and oversight throughout the pilot. Comments must be received by July 22, 2026.

View original listing