FDA Says Nonproprietary Biologics Naming Policy Coming Later This Year

Regulatory NewsRegulatory News | 29 April 2015

The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) plans to release five additional guidance documents by the end of 2015, including one on the nonproprietary names given to biological products, it announced Tuesday.


The 28 April 2015 announcement came in the form of an updated list of guidance documents, known as CDER's "Guidance Agenda." The list is an accounting of all guidance documents the agency plans to release—either in draft or final form—during the current calendar year.

The list is often more ambitious than the agency can manage—many documents on the list will not be published in a given year—but a document's inclusion in the Guidance Agenda is a strong indication that CDER is both interested in and working on a new policy.

CDER first published its 2015 Guidance Agenda in January 2015, when it listed 90 documents for potential publication. One month later, in February 2015, CDER added two additional guidance documents to that list.

Guidance Agenda Additions

CDER's latest update adds five new guidance documents for potential publication:

  • Nonproprietary Naming for Biological Products
  • Qualification of VVSymQ Instrument for the Measurement of Varicose Vein Symptom Burden in Patients with Superficial Venous Incompetence
  • Testicular Toxicity: Evaluation During Drug Development
  • Assessment of Male-Mediated Developmental Risk and Mitigation for Pharmaceuticals
  • Certification Process for Designated Medical Gases

The first guidance document, Nonproprietary Naming for Biological Products, comes just as FDA is preparing a new policy on how it should label biosimilar products. The inclusion of the new guidance document indicates FDA may be taking a more systematic look at the way it labels both biosimilar and innovative biological products.

Another guidance document, on medical gases, would finalize a 2012 draft guidance document by the same name.


CDER Guidance Agenda


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