S 822

The Scientific EXPERT Act of 2025 aims to improve the development of drugs for rare diseases by establishing a process for science-focused drug development meetings. The Food and Drug Administration (FDA) will partner with the Reagan-Udall Foundation to convene these meetings, which will involve experts from various fields like academia, drug development, and patient advocacy. The meetings will focus on identifying challenges, aligning on development approaches, and ultimately informing FDA decisions regarding drug approval and licensing, with a requirement for the FDA to document how meeting input is incorporated into its assessments.