{"url_path":"/register/2026-06-24/2026-12621","section_key":"summary","section_title":"Expedited Investigational New Drug Pilot Program; Request for Information","topic":"register","document":{"doc_type":"Notice","doc_date":"2026-06-24","source_url":"https://www.federalregister.gov/documents/2026/06/24/2026-12621/expedited-investigational-new-drug-pilot-program-request-for-information","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Health and Human Services Department"},"word_count":171,"has_tables":false,"body_markdown":"# Expedited Investigational New Drug Pilot Program; Request for Information\n\n**Type:** Notice\n**Published:** 2026-06-24\n**Citation:** 91 FR 37996\n**Agencies:** Health and Human Services Department, Food and Drug Administration\n**Source:** https://www.federalregister.gov/documents/2026/06/24/2026-12621/expedited-investigational-new-drug-pilot-program-request-for-information\n\n## Abstract\nThe Food and Drug Administration (FDA or the Agency) is opening a public docket to solicit input and comments on a proposal to establish a pilot program, the Expedited Investigational New Drug (IND) pilot program, to shorten the time it takes from drug identification to first-in-human (FIH) study, while protecting clinical trial participants. FDA is requesting information on 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. Information provided through this public docket will help the Agency refine our approach and consider other opportunities to accelerate time to FIH clinical trials."}