USA – Special Protocol Assessment Guidance

This guidance provides information on the procedures and general policies adopted by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for special protocol assessment (SPA).

SPA is a process in which sponsors2 may ask to meet with FDA to reach agreement on the design and size of certain clinical trials, clinical studies, or animal studies3 (i.e., a Request for SPA (hereafter Request); see section III., Eligible Protocols and General Information) to determine if they adequately address scientific and regulatory requirements for a study that could support marketing approval…