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Press Release/Announcement

Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products.

Rockville, MD: US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research; December 7, 2020. 

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January 13, 2021

Rockville, MD: US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research; December 7, 2020. 

Nonprescription drugs are commonly associated with medication errors. This draft guidance seeks to provide a structure for industry to reduce instances of drug name confusion in nonprescription formulas of prescription medications. It describes the US Food and Drug Administration (FDA) vetting process for drug names to improve naming actions prior to submission to the agency. The timeline for submitting comments is early February 2021. 

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Rockville, MD: US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research; December 7, 2020.