Thursday, 23 May 2019

FDA - Nonproprietary Naming of Biological Products


The FDA has issued a new draft guidance document – “Nonproprietary Naming of Biological Products:  Update”.

This draft guidance describes FDA’s current thinking on nonproprietary names of biological products licensed under section 351 of the Public Health Service Act (PHS Act) that do not include an FDA-designated suffix.  Specifically, the nonproprietary names of these products need not be revised in order to accomplish the objectives of the naming convention described in the Guidance for Industry: Nonproprietary Naming of Biological Products (Naming Guidance). 

Similarly, FDA does not intend to apply the naming convention described in the Naming Guidance to biological products that are the subject of an approved application under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as of March 23, 2020, when such an application is deemed to be a biologics license application (BLA) under section 351 of the PHS Act on March 23, 2020 (transition biological products).

In addition, this draft guidance describes FDA’s current thinking on the appropriate suffix format for the proper name of an interchangeable biological product licensed under section 351(k) of the PHS Act. For each interchangeable product, FDA intends to designate  a proper name that is 30 a combination of the core name and a distinguishing suffix that is devoid of meaning and 31 composed of four lowercase letters.


FDA is also reconsidering whether vaccines should be within the scope of the naming convention.

To access the document, see: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM632806.pdf

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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