7 de março de 2019

FDA NEWS: Two New Drafts about Nonproprietary Naming for Biological Products

From: www.fda.gov

FDA relesed today two new documents about Nonproprietary Naming for Biological Products.

In the first DRAFT Guidance for Industry: Nonproprietary Naming of Biological Products: Update", FDA points out that is not proposing changes to any aspects of the final guidance not included for comment in the issued document. 

Among other topics, this draft 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 a combination of the core name and a distinguishing suffix that is devoid of meaning and composed of four lowercase letters. 
The Authority is also reconsidering whether vaccines should be within the scope of the naming convention. 

For now, FDA is seeking for public opinion, and after reviewing the comments received in the docket, intends to revise the Naming Guidance and to promove amendments in some sections, such as sections IV.D and V.B, regarding the subjects addressed in this guidance and issuing a revised final version of the Nonproprietary Naming of Biological Products. 


In the second document, "Manual of Procedures (MAPP), Procedures for Handling Requests for Nonproprietary Name Suffix Review for Biological Products Newly Licensed Under Section 351of the PHS ActFDA emphasizes that the main objective of the naming convention - pharmacovigilance and safe use - can be accomplished by applying the naming convention to biological products at the time they are newly licensed under section 351 of the PHS Act, and without applying it to previously licensed or approved biological products that do not contain suffix in their proper names. 

Thus, this approach is intended to minimize the potential burden on sponsors and the healthcare systems, and to avoid potential confusion for healthcare providers and patients. 

Furthermore, applying the naming convention to all biological products at the time they are licensed is expected to mitigate the risk of inaccurate perceptions of the relative safety and effectiveness of biological products based on licensure pathway.

For information on the guidance and how to comment, please see the Federal Register Notice