It’s All in the Name: FDA Releases Two Guidances for Proprietary Names
(Thursday, December 10, 2020]​

Proprietary names of drugs and biologics are valuable for building the brand recognition and medication preferences of doctors and patients alike. To emphasize the importance of appropriate proprietary names, also called Brand names, of both prescription and non-prescription drugs and biologics, FDA this week released two Guidance Documents to describe the expected practices for drug naming. Since the prescription and non-prescription product names have distinct issues, the two kinds of products each have a dedicated Guidance. The documents describe FDA’s review process for each kind of product including common errors, required name testing studies, tips for what to include and avoid in proprietary names, and ways to avoid confusion in names. These guidance documents are a must-read for the sponsors getting ready for their market approval application. FDA also provides a handy, and in my opinion, fun tool for free to conduct the Phonetic and Orthographic Computer Analysis (POCA) on any name. In our search for several proposed names, we found several near misses and some interesting finds with the POCA tool. This is perhaps the easiest and most productive way to run a quick test on the qualities of a new product name.