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# Comments on Expedited IND Pilot
- URL: https://www.fdaweb.com/comments-on-expedited-ind-pilot/
- Published: 2026-08-25T12:00:00.000Z
- Updated: 2026-09-14T12:05:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161681

Florence Healthcare says the FDA Expedited IND Pilot Program, part of the government’s Operation TrialBlazer, “takes the right premise seriously: that the United States cannot regulate its way past a site infrastructure problem.” In its [response](https://www.regulations.gov/comment/FDA-2026-N-4699-0062?ref=fdaweb.com) to the agency’s Request for Information, Florence’s comments relate to:

- the Qualified Research Institution (QRI) model risks building a credentialing barrier instead of a readiness standard;
- addressing post-IND delay requires fixing how site capacity is measured;
- digital infrastructure standards must bind sponsors and not just sites;
- Institutional Review Board streamlining will underdeliver without addressing local contact review; and
- NIH/NCATS-managed infrastructure should not be the default model for the QRI network.

In its [response](https://www.regulations.gov/comment/FDA-2026-N-4699-0106?ref=fdaweb.com), Amgen says it supports FDA’s goal of accelerating first-in-human clinical trial initiation in the U.S. while preserving critical trial participant safety, scientific rigor, and FDA’s independent regulatory decision-making authority. Its general comments cover:

- preserving sponsor accountability and FDA decision-making authority;
- clarifying the operational and communication model for QRI participation and rolling review;
- establishing objective, fit-for-purpose QRI qualification criteria; and
- modernizing and streamlining clinical trial frameworks.

The Cleveland Clinic [says](https://www.regulations.gov/comment/FDA-2026-N-4699-0029?ref=fdaweb.com) academic medical centers can play an important role in improving IND quality, strengthening safety assessment, and providing multidisciplinary clinical and translational expertise. However, it says, pilot success will depend on clearly defined roles, standardized review processes, robust conflict-of-interest safeguards, structured FDA-QRI-sponsor engagement, transparent evaluation metrics, and maintenance of FDA’s ultimate regulatory authority.