Nonproprietary Naming of Biological Products: Update; Draft Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Nonproprietary Naming of Biological Products: Update." This draft guidance describes FDA's current thinking on nonproprietary names of biological products licensed under the Public Health Service Act (PHS Act) that do not include an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 to accomplish the objectives of the naming convention described in the final guidance for industry, "Nonproprietary Naming of Biological Products," dated January 2017. Similarly, FDA does not intend to apply the naming convention described in the final guidance for industry, "Nonproprietary Naming of Biological Products," to biological products that are the subject of an approved application under 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 the PHS Act (transition biological products). FDA is also reconsidering whether vaccines should be within the scope of the naming convention. In addition, the draft guidance descr