FDA Issues Draft Guidance for Developing Proprietary Names for Drugs

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 06-02-2014 12:40


FDA is issuing draft guidance, Best Practices in Developing Proprietary Names for Drugs, to help sponsors of human drugs, including those that are biological products, develop proprietary names that do not cause or contribute to medication errors or otherwise contribute to the misbranding of the drug. The guidance describes design practices to help avoid such errors with proprietary names and provides a qualitative systematic framework for evaluating proposed proprietary names before submitting them for FDA review. This guidance does not address the selection of established names or proper names.

The draft guidance applies to all human prescription and nonprescription drug products, including those that are biological products.

The draft guidance is the last in a series of three guidance documents that FDA is issuing to help sponsors minimize the potential for medication errors when designing and developing products. The first guidance focuses on minimizing risks associated with the design of the drug product and its container closure system (see draft guidance Safety Considerations for Product Design to Minimize Medication Errors , December 2012). The second guidance focuses on safety aspects of the container label and carton labeling design (see  FDA draft guidance for industry Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors , April 2013). This third draft guidance presents FDA’s current thinking on best  practices for developing and selecting proposed proprietary names.

Source: FDA



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