FDA Issues Final Guidance on Proprietary Names

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 04-05-2016 15:14


The US Food and Drug Administration (FDA) has issued final guidance, Contents of a Complete Submission for the Evaluation of Proprietary Names,which describes for industry the information that the FDA uses to evaluate proposed proprietary names for certain drugs, including biological products, within the time frames set out in Prescription Drug User Fee Act (PDUFA IV) performance goals.

This guidance is intended to assist industry in the submission of a complete package of information that FDA will use in the assessment of:the safety aspects of a proposed proprietary name, to reduce medication errors, and the promotional implications of a proposed proprietary name, to ensure compliance with other requirements for labeling and promotion using traditional review methods.

The guidance applies to proprietary name submissions for the following types of products: (1) prescription drug products, including biologics, that are the subject of an investigational new drug application (IND), a new drug application (NDA), an abbreviated new drug application (ANDA), or a biologics license application (BLA) and (2) nonprescription drug products that are the subject of an IND, NDA, or ANDA.

This guidance does not describe the methods used for evaluation of proposed proprietary names using the agency's traditional review process, nor does the guidance describe the information needed by the FDA to evaluate proposed proprietary names under the voluntary two-year pilot program being conducted by the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research. That information can be found in the FDA concept paper entitled “PDUFA Pilot Project Proprietary Name Review,” dated September 2008.

Source: US Food and Drug Administration


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