Stakeholder Outreach for Cell and Gene Therapy

The Food and Drug Administration is seeking support for stakeholder outreach initiatives focused on cell and gene therapy to fulfill CBER commitments under PDUFA VII and proposed goals for PDUFA VIII. The primary objective is to expand FDA capacity in the cell and gene therapy space by enhancing stakeholder education and interaction through various communication platforms. Key activities include the development and delivery of webinars, recorded trainings, and the management of initiatives such as RegenMedEd, Virtual Town Halls, and guidance summary webinar series. These efforts are designed to support broader FDA priorities, including transparency in regulatory communications and patient-focused drug development. By strengthening outreach and education, the agency aims to facilitate better interaction with industry stakeholders and ensure a comprehensive flow of information regarding regulatory expectations and processes.