The Scientific EXPERT Act of 2025 amends the Federal Food, Drug, and Cosmetic Act to create a new process for externally led, science-focused drug development meetings (EL-SFDD meetings). These meetings aim to bring together medical experts, drug sponsors, scientific organizations, and patient groups to discuss scientific challenges and identify novel approaches for developing drugs for rare diseases and conditions . The ultimate goal is to facilitate the development, review, and approval of treatments to address unmet medical needs in this area. Under this process, the Reagan-Udall Foundation for the FDA is tasked with convening a minimum of four EL-SFDD meetings annually, with each meeting focusing on a different rare disease or group of diseases. A permanent Multistakeholder Steering Committee will advise the Foundation, recommending meeting topics based on criteria such as unmet therapeutic needs, patient population size, and the potential for increased regulatory flexibility. This committee will comprise representatives from the FDA, academia, patient groups, and industry. In planning these meetings, the Foundation will consult with stakeholders to develop specific objectives and agendas, and appropriate representatives from FDA review divisions are required to participate. Following each meeting, the Foundation must publicly release a transcript, recording, and a summary analysis of the input received, highlighting areas of consensus and agreed-upon next steps. Furthermore, when approving or licensing a drug, the Secretary must disclose if a relevant EL-SFDD meeting occurred and how its input influenced the risk-benefit assessment . The bill also mandates an annual report to Congress summarizing the number and topics of meetings held, the extent of FDA participation, and how meeting input was utilized in drug development and regulatory decision-making. This ensures transparency and accountability regarding the impact of these collaborative efforts. To support these initiatives, $1,000,000 is authorized to be appropriated for each of fiscal years 2026 through 2030.