OTC Umbrella Branding Soaked By Regulatory Storm In Draft Guidance – CHPA

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 FDA’s draft guidance also renders useless OTC manufacturers’ expertise in conducting tests to determine whether consumers safely self-select nonprescription drugs based on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FDA’s draft guidance on developing proprietary drug names needlessly limits OTC firms’ use of umbrella branding, the Consumer Healthcare Products Association argues in suggesting the agency write a separate guidance for over-the-counter drugs.

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