Additions to Guidance Agenda for 2015

The FDA has published a revised listing of its new Guidance agenda for 2015 with a number of additions.  The full document can be found here.   The listing provides an outline of the guidance document that FDA expects to issue in the current year.

The most notable addition is a Guidance on the Nonproprietary Naming for Biological Products.  This is something the biosimilars world has been looking for and its significance is clear after the FDA approved the first biosimilar with a suffix to identify a particular firm’s product.   The debate relative to naming of biosimilars is intense with both sides digging in their heels.  The question is, does the inclusion of differentiation of the same biosimilar with different names serve the public and healthcare providers, or does it thwart the intent of the biosimilars legislation?  The industry is eager to see where the Agency lands on this one.

Other additions to the list include:

  • 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
  • Formal Dispute Resolution: Appeals Above the Division Level

The Guidance Agenda is usually issued before the start of the year to give industry a look into what the Agency sees as priority guidance development for the year.  The FDA typically updates the list once or twice a year, as new topics the Agency has decided to concentrate on go into the guidance development process.  This year’s list is certainly ambitious.  Let’s keep our eyes open and monitor their progress.