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- 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.
www.addisonwhitney.com › insights › medication-safety-and-drug-namingNavigating Medication Safety in Drug Naming - Addison Whitney
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What are the best practices for proprietary name-related medication?
What are the best practices for proprietary name-related medication errors?
What is the prescription medication naming guidance?
What is FDA's 'best practices in developing proprietary names?
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.
Feb 2, 2021 · We further noted, about the 2014 guidance: “The concept behind this draft guidance is simple: It is important for safety reasons that the written proprietary name not look like that of another proprietary name nor sound like another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.
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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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 ...
Dec 23, 2020 · Look-alike and sound-alike names weaken the safety of medication use. This guidance provides a structure for industry to reduce instances of drug name similarities and describes the US Food and Drug Administration (FDA) vetting process for drug names to improve naming actions prior to submission to the agency.
FDA’s Interest in Proprietary Names for Drugs • Proprietary name is a critical element in use of drug products • Proprietary names that are similar phonetically or in their spelling or orthographic appearance or are otherwise confusing or misleading, may lead to errors. • Medication errors are a significant public health concern
Dec 9, 2020 · FDA is announcing the availability of a guidance for industry entitled “Best Practices in Developing Proprietary Names for Human Prescription Drug Products.” This guidance describes best practices to help minimize proprietary name-related medication errors and otherwise avoid adoption of proprietary names that contribute to violations of ...
