Federal Register #FDA-2026-N-3947

FDA Request for Information on Impacts of Patient-Focused Drug Development Meetings

The Food and Drug Administration (FDA) is seeking stakeholder input on the impacts of patient-focused drug development (PFDD) meetings. - Government Buyer: - Department of Health and Human Services - Food and Drug Administration (FDA) - No OEMs or vendors are specified; this is not a procurement for goods or services. - Products/Services Requested: - Request for information and examples regarding the effects of PFDD meetings - No physical products or services are being purchased - Unique/Notable Requirements: - Respondents should provide specific examples and supporting data - Input should address how PFDD meetings have influenced community engagement, research, advocacy, drug development, and clinical practice - Purpose: - To inform future FDA strategies and understand the broader impact of PFDD meetings

Description

The Food and Drug Administration (FDA) is establishing a public docket to collect examples about how previous patient-focused drug development (PFDD) meetings have impacted stakeholders' drug development efforts. This includes impacts on community engagement, research priorities, advocacy strategies, medical product development programs, clinical practice, and other areas of interest. The FDA invites input from patient organizations, medical product developers, healthcare providers, and academic researchers to provide detailed information and comments on the outcomes of these meetings. Comments must be submitted by June 30, 2026.

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