Combination Product Industry News & Guidance

The FDA has been extra busy this summer! Another key draft guidance has been published – this newest one on Use-Related Risk Analysis (URRA) for drugs, biologics, and combination products.

This draft guidance was developed by DMEPA (CDER) but has been signed by all three medical product centers (CDER, CBER, CDRH) as well as the Office of Combination Product (OCP).

What you will find in the draft guidance:

• Heavy reference to existing FDA guidance and recognized consensus standards.
  
• Formalization of the content expected in a URRA, which was only mentioned at a high level in some prior guidance documents.
  
• Some common examples (including from PFS and AI combination products)
  Explanation of the FDA’s thinking in the drug-delivery combination product context, which should help in consistency of content.
  
• Explicit confirmation that HF data may be needed for non-combination product drugs or biologics, particularly those with ‘complicated dosing,’ however, there is little detail on what situations may constitute ‘complicated dosing.’
  
• Clarification of situations where a right-of-reference may be required to leverage data from other products or manufacturers.
  
• Explicit mention that a URRA (and, potentially, comparative or threshold analysis) should not be submitted along with an HF Summative Validation protocol if the sponsor is arguing against completing such a study – if FDA determines one is necessary, then that may be reviewed in a subsequent request.
  
  If you have any questions on how this draft guidance will affect your own combination product submissions, or need support in preparing a URRA or submission utilizing a URRA, feel free to use our contact form or reach out directly for a discussion discuss@suttonscreek.com.

AUTHOR

Jonathan Amaya-Hodges, Director, Technical Services, Suttons Creek, Inc. – Jonathan has over 16 years of multidisciplinary experience in regulated medical products (drugs, biologics, medical devices, and combination products) at multiple global companies. He has practical experience in Development/Engineering, Quality Assurance, and Regulatory Affairs for various types of combination products with a focus on drug delivery. Additional background includes digital health (including smart packaging/connected devices and software as a medical device, or SaMD) and in vitro diagnostics, along with clinical development (bridging) and lifecycle management for combination products. Jonathan engages with the global combination product community by speaking at conferences, lecturing in courses, serving key roles within prominent industry organizations, and interfacing with regulators on a variety of topics.