Human factors/usability analysis is gaining prominence in the dialogue between combination product manufacturers and regulators. At issue is an effective pathway for companies to follow in conducting and submitting the analysis and for regulators to follow in reviewing it.
As industry and regulators work to strengthen the CMC, GMP and clinical testing foundation for regulating the expanding variety of combination products (CP) and technologies, the “usability-by-design” expectations are emerging as an important fourth component.
The increasing focus on usability requirements among device regulators in the U.S. and Europe is pushing the drug and biologic regulatory community involved in combination products to come to grips with how the requirements should play out in the CP context.
The challenges in approaching HF/usability analysis include understanding: ● the different role that it plays versus traditional clinical testing ● where the responsibility should lie in the companies involved ● what needs to be submitted and where ● how the agency review and interaction takes place ● the qualitative vs. quantitative nature of the data ● the implications for post-approval monitoring, complaint handling and CAPA ● what is needed to effect post-approval changes, and ● the expectations for generic products.
The growing attention on the HF/usability component of the regulatory picture for combination products was marked by the inclusion of a session focused specifically on the topic at the 2011 Conference of the International Pharmaceutical Aerosol Consortium – Regulatory Science (IPAC-RS) held in Rockville, Maryland at the end of March.
Representing the human factors program within the Office of Device Evaluation (ODE) at FDA’s Center for Devices and Radiological Health (CDRH) was Ron Kaye, who leads the office’s Human Factors and Device Use Safety Team.
Also presenting at the session was Pfizer Global R&D New Products CMC Research Fellow Paul Lucas, who provided the perspective of the IPAC-RS’ Device Working Group (DWG) on the regulatory expectations for user testing. A third presentation, focused specifically on human factors in the design of inhalation devices, was given jointly by Vectura Device Development Director Stephen Eason and Team Consulting User Research Head Julian Dixon.
[The key insights offered by the regulator and industry experts at the IPAC-RS HF/usability session are provided for subscribers here. The full story can be purchased for $95 by contacting Jonathan Trethowan (Jonathan@ipq.org). For subscription information click here.]
Recent IPQ coverage on combination products:
More Guidance Forthcoming from FDA’s Office of Combination Products on CMC & GMP Expectations
Communication with Reviewing Authorities Key to Combination Product Success in Europe and Japan
Risk-based Approach to Combination Products Advocated to Improve Communications with Regulators and Streamline Filing