CDER Publishes Manual of Policies for Safety Outcomes Trial Subcommittee

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.