Comment from Program On Regulation Therapeutics, And Law (PORTAL)

Summary: The Cancer Innovation and Regulation Initiative in the Program On Regulation, Therapeutics, And Law (PORTAL), an academic research center based at Harvard Medical School and Brigham and Women’s Hospital, opposes the current design of the CNPV Pilot Program. They argue that the program risks politicizing regulatory decisions, eroding public trust, and imposing an unfunded mandate on FDA staff without meaningfully improving clinical development timelines.