The Name of the Game: Adjusting to a Tougher FDA Brand Name Review Process
This article was originally published in RPM Report
FDA has historically rejected about a third of proprietary names proposed by drug sponsors. But that rate is on the rise as the agency implements changes to the review process based on post-marketing drug safety experience. For drug sponsors, that could really muck up launch plans.
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CDER now granting 86% of sponsors’ preferred proprietary names prior to launch – a significant improvement over just five years ago that seems driven in part by several new guidance documents.
FDA’s Center for Drug Evaluation & Research is now granting 86% of drug sponsors’ preferred proprietary trade names prior to launch – a significant improvement over just five years ago. Better communication between FDA and drugs sponsors – including the development of several new guidance documents – has resulted in a much more predictable review of proprietary trade names.