Stakeholder Outreach for Cell and Gene Therapy
Past New Requirement Updated
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $250,000 to $700,000
- Set-aside
- No set-aside
Forecast facts
- Anticipated award
- NAICS code
- Not on record
- Points of contact
-
- CBER Acquisition Liaison cberacquisitions@fda.hhs.gov
Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.
About this forecast
The Food and Drug Administration is procuring stakeholder outreach services for cell and gene therapy, with an estimated solicitation release date of October 1, 2026, and an estimated award date of December 1, 2026. The work supports CBER's PDUFA VII commitments and proposed PDUFA VIII commitments to expand FDA capacity in the cell and gene therapy space through webinars, recorded trainings, and stakeholder education platforms including RegenMedEd, Virtual Town Hall, and guidance summary webinar series. These outreach efforts align with FDA priorities including patient-focused drug development and transparency in regulatory communications.
The estimated award value ranges from $250,000 to $700,000. Inquiries should be directed to cberacquisitions@fda.hhs.gov.
Forecast text
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.
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