To maximize the agency’s efforts to process submissions for the evaluation of proprietary names within the deadlines under the Prescription Drug User Fee Act (PDUFA), FDA issued a guidance document to assist manufacturers in making a complete submission, which is required for the PDUFA review clock to begin. FDA discusses the collection of information that the agency requires to assess: (1) the safety aspects of a proposed proprietary name in order to reduce medication errors, and (2) the promotional implications of a proposed proprietary name, to ensure compliance with other requirements for labeling and promotion using traditional FDA review methods.