When it comes time to name your pharmaceutical brand asset, there are important regulations to keep in mind. Gaining approval on a product name can impact your ability to stay on track for a product launch timeline.
In 2017, the FDA published an industry guide on the Nonproprietary Naming of Biological Products. This guide is an excellent resource for pharma leaders.
When submitting a product name to the FDA for approval, it is critical to start early and partner with an expert, according to Addison Whitney, part of INC Research/inVentiv Health. In her piece in FiercePharma, Addison recommended:
"Ensure you are leaving enough time for creating a strategy and getting legal, regulatory and commercial teams collaborating from the beginning to assess risks and potential strategies for addressing those risks. Time is also needed to screen candidate names. When it comes to naming your asset, find a partner – a company with both brand naming and regulatory experience – to guide you through these milestones and to develop the best regulatory submission strategy for your product."