Impacts of Patient-Focused Drug Development Meetings; Establishment of a Public Docket; Request for Information and Comments

https://www.federalregister.gov/documents/2026/05/01/2026-08524/impacts-of-patient-focused-drug-development-meetings-establishment-of-a-public-docket-request-for?utm_medium=email&utm_source=govdelivery Impacts of Patient-Focused Drug Development Meetings; Request for Information and Comments FDA is issuing a request for information and comments to collect examples about how previous patient-focused drug development (PFDD) meetings have impacted stakeholders’ drug development efforts. In response to stakeholder requests to better understand the outcomes of PFDD meetings, FDA is seeking to collect information about their impacts outside of specific regulatory decisions. The Agency recognizes that there are many significant outcomes, such as community engagement, research priorities, advocacy strategies, medical product development programs, clinical practice, and other areas, that can occur in forums to which FDA is not typically a party. Similarly, changes made by medical product developers in response to patient input may not be communicated to FDA outside of a formal regulatory submission. FDA invites input from all interested parties, including patient organizations, medical product developers, healthcare providers, and academic researchers. FDA encourages written comments to the public docket by June 30, 2026. https://www.regulations.gov/document/FDA-2026-N-3947-0001?utm_medium=email&utm_source=govdelivery