The FDA began reviewing drug names beginning in the early 1990’s. However, it was a landmark report published in 1999 by the Institute of Medicine, linking drug name similarity to medication error, that led the FDA to increase its attention to and oversight of this part of the overall drug
approval process. EMEA began examining “invented” names in 1995 and set up a specific working group to oversee the process in 1999. Both agencies initiated proprietary nomenclature assessment in the interest of public health and safety. This was based on the belief that names that sound alike or look alike can cause confusion, and in the worst cases, lead to medication error. Both FDA and EMEA share similar philosophies about proposed drug names.
In general, they should not be: phonetically or visually similar to existing drug names or names pending approval, encode or be similar to generic/INN nomenclature, or convey promotional, misleading, unsubstantiated, or inappropriate claims.
posted by pompomtom at 9:49 PM on August 29
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