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To embed, copy and paste the code into your website or blog: 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 ....
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 guidan ....