Umbrella Branding Is ‘Particular Concern’ As FDA Requests Research Proposals
This article was originally published in The Tan Sheet
FDA seeks research proposals to evaluate consumers’ understanding of OTC drugs bearing umbrella brand names. The agency says the data also will benefit regulatory action and future guidance development as well as provide knowledge to scientists studying risk communication of drugs.
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The trade group recommends FDA write a separate proprietary name guidance for OTC drugs. FDA’s draft guidance also renders useless OTC manufacturers’ expertise in conducting tests to determine whether consumers safely self-select nonprescription drugs based on labeling, CHPA says in comments.
FDA’s draft guidance on developing proprietary drug names recommends steps to evaluate a proposed name, including testing names with health care professionals. The draft notes that OTC “brand name extensions have posed problems when the same root proprietary name is used for multiple products.”
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