CDER Guidance Agenda

Issued by: Center for Drug Evaluation and Research

This is the list of guidances that CDER is considering for development during calendar year 2026. The list includes first issuance of a level 1 draft guidance and level 1 guidances previously issued and being revised. We currently intend to develop guidance documents on these topics, but we are not bound by this list of guidances, nor required to issue every guidance document on the list.  We are not precluded from developing guidance documents on topics not on this list.