How Long Does It Take To Change A Name?
Three-month timeframe for nonproprietary name changes of two botulinum toxin products is unlikely to be replicated for the dozens of currently licensed biologics subject to FDA’s requirement for distinguishable suffixes.
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Executive order mandating two existing regulations be eliminated for every new one issued includes guidances, raising questions about how FDA will communicate with industry going forward.
Final guidance adds new factors for biosimilar and innovative sponsors to consider in developing distinguishable suffixes for nonproprietary names but FDA is unswayed by calls for meaningful suffixes derived from license holder’s name; timing of retrospective application to previously approved products remains in question.
Most biologics will have random four-letter suffix added to nonproprietary name, but FDA asks a number of questions about potential alternatives.