Creates a formal program for externally led, science‑focused meetings on rare diseases to inform drug development. The Reagan‑Udall Foundation must run at least four meetings each year, manage a permanent steering committee, and plan meetings in consultation with FDA staff and stakeholders.

To increase transparency, transcripts and summaries must be published within 180 days. The FDA must state publicly when a meeting helped inform an approval or licensure decision, and there will be annual reports to Congress. The law clarifies these meetings can inform, but not direct or replace, FDA regulatory decisions, and authorizes $1,000,000 per year for fiscal years 2026–2030.