Guidance on Complete Submissions for the Evaluation of Proprietary Names
This post was written by Paul Sheives.
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.
