USA – Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2020

This is the list of guidance topics CBER is considering for development during Calendar Year
2020. 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…