The Name of the Game: Adjusting to a Tougher FDA Brand Name Review Process
This article was originally published in RPM Report
Executive Summary
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.
You may also be interested in...
How To Choose A Proprietary Rx Drug Name
US FDA final guidance describes possible study design to test whether selected names may misbrand a drug. Agency also okays use of two-letter USAN stems in product names and clarifies use of modifiers.
Brand Name Review By FDA: Predictability Returns To Process
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.
CDER Brand Name Reviews: Predictability Returns To Process
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.