Brand Name Review By FDA: Predictability Returns To Process

18 Apr 2016

• By Kate Rawson

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.

The Food & Drug Administration’s brand name review process appears to have settled into a more comfortable and predictable part of the new drug review process thanks to recently issued and updated guidance documents for industry on best practices.

The Center for Drug Evaluation & Research approved 86% of proprietary trade names submitted by sponsors of new drugs and...