In February 2025, the FDA finalized its guidance on written procedures for Institutional Review Boards (IRBs), clarifying long-standing expectations around IRB SOPs. While many IRBs already have procedures in place, this updated FDA guidance provides additional specificity on what must be documented and how it should be maintained.
In this article, the Univo IRB team breaks down the finalized guidance and offers practical insight on how to align your IRB procedures with FDA expectations.
Read it now to explore:
- What the FDA’s finalized IRB SOP guidance includes
- Common gaps and oversights during inspections
- How Univo helps IRBs and research teams stay aligned and audit-ready
