FDA Rejecting Fewer Proprietary Names
This article was originally published in RPM Report
The Center for Drug Evaluation & Research granted 74% of the proprietary names it evaluated between October 1, 2013 and August 31, 2014. That is a big improvement from rejection rates of over 50% just a few years ago.
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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.
A pilot program for reviewing proposed proprietary names for branded drugs and biologics has been terminated by FDA due to a lack of participation by industry. PhRMA thinks the agency should go a step further and abolish the brand name testing process altogether. Will that fly with FDA?