Comment from EHY Consulting LLC

EHY Consulting LLC appreciates the opportunity to provide comments in response to the Expedited Investigational New Drug (IND) Pilot Program Request for Information. The attached comments support FDA's efforts to accelerate promising therapies while emphasizing that patient safety, trusted evidence generation, and a strong U.S. biomedical innovation ecosystem are mutually reinforcing objectives. The recommendations focus on practical approaches to strengthen regulatory confidence through manufacturing integrity, clinical data stewardship, verification, and regulatory transparency while preserving the long-term ability of U.S. patients to access safe, effective, and innovative therapies. For additional context, I have also included my recent testimony before the U.S.-China Economic and Security Review Commission and previously submitted comments to the Department of Health and Human Services regarding clinical AI governance. These supporting materials reflect a consistent analytical framework regarding data stewardship, trusted innovation, and resilient biomedical capability across multiple federal policy discussions. Thank you for the opportunity to contribute to this important initiative.