US FDA: User-Error Risks Grow When OTC Brands Extend With Different Ingredients, Indications
US FDA encourages firms to “identify and avoid potential problems before the product is marketed” by comparing proposed names against the agency’s best practices recommendations and seeking the agency’s input.
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Extending an OTC brand name to a product with a different active ingredient and indication creates a margin for error in the marketplace, FDA says. Recommendations include best practices to help minimize name-related medication errors and a framework FDA uses in evaluating proposed propriety names.