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- The regulatory complexities and regional variations in drug nomenclature as well as potentially confusing names of drugs, such as look-alike and sound-alike, are potential risks for medication errors that could cause serious harm to the patients.
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Dec 17, 2020 · By Karen K. Won. Last week, the Food and Drug Administration (“FDA”) issued a pair of Guidance for Industry documents outlining best practices for developing proprietary names (i.e. brand names) for prescription and nonprescription human drug products.
But why is this important when it comes to naming your asset? Success in determining an appropriate name for a drug product is rooted in uniqueness and creativity, while avoiding potential confusion – from both a trademark standpoint and a medication safety standpoint – to prevent medication errors.
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Mar 25, 2024 · Challenges in Drug Naming. Despite the systematic approach to drug naming, there are still challenges that need to be addressed. Avoiding Confusion. One of the biggest challenges in drug naming is avoiding confusion with existing drug names. This is crucial for patient safety, as confusion can lead to medication errors. Global Consistency
18 [Drug] If the Active Ingredient is a: •“Non-salt” (e.g. ester, chelate, complex) –use the entire drug substance name •Salt –generally, use the name of active moiety –sometimes ...
Feb 2, 2021 · We further noted, about the 2014 guidance: “The concept behind this draft guidance is simple: It is important for safety reasons that the written proprietary name not look like that of another proprietary name nor sound like another proprietary name when spoken.
Dec 9, 2020 · This guidance describes best practices to help minimize medication errors and otherwise avoid adoption of proprietary names that contribute to violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations and provides a voluntary framework for evaluating proposed proprietary names before submitting them for F...
Jul 19, 2022 · Who names drugs? Drugs get both a brand, or proprietary, name and a generic name that is nonproprietary. Each is assigned in a slightly different process. As long as a drug compound isn’t...
