FDA Draft Guidance On Proprietary Names

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Updated February 3, 2021

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Best Practices in Developing Proprietary Names for Human Prescription Drug Products - Guidance for Industry - FDA.gov (PDF)

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This just released by the FDA, "Draft Guidance for Industry on the Contents of a Complete Submission for the Evaluation of Proprietary Names; Availability." This guidance, "provides recommendations to industry regarding the submission of a complete package that FDA intends to use to assess the safety of proposed proprietary drug and biological product names and other factors that, in association with the name, can contribute to medication errors. In addition, FDA intends to use this information in the assessment of promotional aspects of proposed proprietary names."

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