
FDA Publishes Best Practices for Developing Proprietary Names for Drugs
The new guidance document is intended to minimize medication errors and avoid violations of the FD&C Act.
On Dec. 8, 2020, FDA announced the publication of
“This guidance is intended to provide clarity and transparency to sponsors on the factors and systematic framework FDA uses to evaluate proposed proprietary names for prescription drugs and to recommend best practices for sponsors considering such names. Using the best practice recommendations and other assessment tools addressed in this guidance is not mandatory, and applying them does not dictate specific outcomes. Assessments of a proprietary name are necessarily fact-specific, and therefore, FDA’s determinations are made on a case-by-case basis, considering the totality of the information,” the guidance states.
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