Expedited Investigational New Drug Pilot Program; Request for Information
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The 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.
- Tags
- health IT, Notice, Health and Human Services Department, Food and Drug Administration
- Related exam domains
- CISSP 4: Communication and Network Security; CISM 2: Information Security Risk Management; CISM 3: Information Security Program; CISA 2: Governance and Management of IT; CISA 5: Protection of Information Assets
- Source record id
- 2026-12621
- First seen by InfoSec Signals
- Sep 23, 2026
Source: Federal Register API, Office of the Federal Register, National Archives and Records Administration about this source more from it
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