CDER released policies and procedures that describe the responsibilities of the Safety Outcomes Trials Subcommittee when evaluating safety data.

The subcommittee will serve the following primary functions: provide advice to Office of New Drugs review divisions when SOTs are being considered as pre- or post-approval requirements; catalog and analyze the ongoing experience with SOTs to inform future decision making; and assist in the development of guidance documents that articulate principles and best practices for the development and conduct of SOTs.