Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2026

This is the list of guidance topics the Center for Biologics Evaluation and Research (CBER) is considering for development during Calendar Year 2026. The list includes topics that currently have no guidance associated with them, topics where updated guidance may be helpful, and topics for which CBER has already issued Level 1 draft guidances that may be finalized following review of public comments. We currently intend to develop guidance documents on these topics; however, the Center is neither bound by this list of topics, nor required to issue every guidance document on this list. We are not precluded from developing guidance documents on topics not on this list. In addition, we also submit lists of intended regulations to the Unified Regulatory Agenda available at https://www.reginfo.gov/public/do/eAgendaMain. For further information regarding specific topics or guidances, please contact the Center for Biologics Evaluation and Research, Food and Drug Administration, industry.biologics@fda.hhs.gov. Guidance Documents CBER is Planning to Issue in 2026