FDA Releases Draft Guidance on Naming System for Biological Products, Seeks Public Comment

To ensure the safe use of biological products, Food and Drug Administration (FDA) has developed draft guidance for industry on the nonproprietary naming of biological products. The draft guidance, “Nonproprietary Naming of Biological Products,” details the FDA’s proposed naming convention that is intended to prevent inadvertent substitution of biological products that are not interchangeable and to support the safety monitoring of post-market products, according to an FDA Voice blog post. FDA seeks public comment regarding the proposed naming convention, and has also requested public comment on the “benefits and challenges of other naming approaches.” Instructions for submitting comments on the draft guidance can be found in the Federal Register announcement, and the deadline to submit comments before FDA begins work on the final guidance is October 27, 2015.
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