Public Comment
Comments provided on: August 24, 2026
Comments provided to: FDA
Description: The MRCT Center submitted a public comment to FDA on the request for information on the proposed “Expedited Investigational New Drug Pilot Program.” The MRCT Center comments support FDA’s goal of accelerating first-in-human studies but caution that the proposed pilot could unintentionally add complexity, cost, and potential conflicts of interest unless QRI roles, standards, accountability, and interactions with FDA are clearly defined and standardized. The submission recommends a more flexible and inclusive QRI model, stronger safeguards for independence and confidentiality, a centralized review platform, transparent performance metrics, and evaluation based on end-to-end development timelines and participant safety rather than speed alone.