Combination Product Industry News & Guidance

Newest FDA Draft Guidance on Prescription Drug-Use-Related Software Will Be a Tool on Your Journey to Filing Success

The FDA has shared a new draft guidance this month on PDURS (prescription drug-use-related software), which includes cross-center content (CDRH, CDER, CBER, and OCP all signed onto this guidance). Pharmaceutical manufacturers take note because software is a growing space that is generating ever-increasing interest. And, since in many of these cases, software is used in connection with a combination product like an inhaler or autoinjector, those of us in the Combination Products business should pay close attention to this draft guidance as well.

This guidance is developed much further than the initial framework described in the 2018 Federal Register Notice. Combination products are referenced throughout; both connected (where the combination product provides some output to the software, such as when a dose is taken) and non-connected uses are described and classified. The FDA has done a good job of differentiating when the PDURS leads to a ‘clinically meaningful benefit’ (and can be described within the PI) vs. not. While not fully detailed (due to the broad possibilities), it definitely provides a start to explain the FDA’s thinking and, most importantly, help our industry create – along with proactive engagement with the FDA – the nuanced strategies needed to achieve filing success.

Our Principal Consultant, Rita Lee, PhD, RAC, will be speaking on connected health opportunities and complexities for inhalation devices later this month at RESCON. Visit our home page for more information on this engagement or to set up a time to speak with Rita and our connected software specialists about your related projects and planning.

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.