Federal Register #FDA-2026-N-4699

FDA Request for Information: Expedited IND Pilot Program for 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: - Request for information (RFI) regarding the design and implementation of a pilot program to accelerate the timeline from drug identification to first-in-human (FIH) clinical trials - Program Details: - Establishment of a network of Qualified Research Institutions (QRIs), including academic medical centers, healthcare networks, contract research organizations, regulatory advisors, and third-party review organizations - QRIs will 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 rolling submissions, and accelerate clinical trial initiation - FDA will retain full regulatory authority and oversight - Products/Services Requested: - No specific products, OEMs, or purchase quantities are requested - Solicitation is for information, comments, and recommendations from stakeholders on the pilot program's structure and requirements - Unique Requirements: - Emphasis on collaboration between FDA, QRIs, and sponsors - Focus on maintaining participant safety while expediting clinical trial processes - Input sought on network structure, review processes, and implementation challenges

Description

The Food and Drug Administration (FDA) is extending the comment period for a notice published on June 24, 2026, which opened a public docket to solicit input and comments on a proposal to establish a pilot program called the Expedited Investigational New Drug (IND) pilot program. This program aims to shorten the time from drug identification to first-in-human (FIH) study while ensuring the protection of clinical trial participants. The extension allows interested persons additional time to submit comments until August 24, 2026.

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