FDA Issues New Guidance on Drug Naming : vimarsana.com

FDA Issues New Guidance on Drug Naming


FDA Issues New Guidance on Drug Naming
Thursday, December 17, 2020
Last week, the Food and Drug Administration (“FDA”) issued a pair of Guidance for Industry documents outlining best practices for developing proprietary names (i.e. brand names) for prescription and nonprescription human drug products.  The documents provide the agency’s current framework and recommendations for the notoriously unpredictable approval process for drug brand names that do not contribute to medication errors, particularly those attributable to nomenclature issues. 
Prescription human drugs:  “Best Practices in Developing Proprietary Names for Human Prescription Drug Products” updates the FDA’s prior guidance on this topic.  The document provides an overview of the FDA’s objective and review process concerning proprietary names for human prescription drug or biologic products, along with recommendations for the sponsor’s name development process.  The guidance sets forth objective criteria the sponsor can pre-screen in candidate names; additional name traits prone to confusion, which the FDA will assess on a case-by-case basis; description of the agency’s name simulation studies and suggested methodology for (optional) sponsor-conducted name safety studies; and explanation of the Phonetic and Orthographic Computer Analysis (“POCA”) algorithm and its results.  The guidance also addresses specific situations such as the use of brand modifiers and adopting dual proprietary names.   

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