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OTC Umbrella Branding Soaked By Regulatory Storm In Draft Guidance – CHPA

This article was originally published in The Pink Sheet Daily

Executive Summary

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 FDA’s draft guidance also renders useless OTC manufacturers’ expertise in conducting tests to determine whether consumers safely self-select nonprescription drugs based on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.

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US FDA: User-Error Risks Grow When OTC Brands Extend With Different Ingredients, Indications

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Concerned By Confusion Over OTC Drug Brands, US FDA Offers Guidance On Developing Names

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