Stakeholder Outreach for Cell and Gene Therapy

Part of CBER's PDUFA VII commitments and proposed commitments for PDUFA VIII are to increase FDA capacity in the cell and gene therapy (CGT) space to expand stakeholder outreach via webinars and recorded trainings and to facilitate industry and stakeholder education and interaction. Broad stakeholder communications platforms, like the RegenMedEd, Virtual Town Hall and guidance summary webinar series are integral pillars of OTP's outreach and education campaign, help fulfill the goals of CBER'S CGT stakeholder commitments, and support FDA priorities such as patient-focused drug development and transparency in regulatory communications.

Estimated value

>= $250K and < $700K

Est. solicitation date

Oct 1, 2026

Anticipated award

Dec 1, 2026