FDA Guidance Updates IRB Written Procedures

The FDA is simplifying the process of developing written procedures for an IRB, providing industry with a comprehensive checklist that satisfies both FDA and HHS requirements.

In an update to a nearly two decade-old document, the agency addressed frequently asked questions on the content of IRB procedures. The draft guidance released takes into account variations in procedures due to the type of research being conducted, institutional policies as well as state and local laws.