The Center for Research on Complex Generics (CRCG) is seeking experts to form an Expert Committee (EC) focused on establishing rigorous methods for evaluating human factors (HF), device operability, and user interface design in the context of demonstrating equivalence of generic drug-device combination products (DDCPs), which is a significant scientific and regulatory challenge for generic DDCP developers. Generic DDCPs, including product classes such as inhalers, injectors, and transdermal systems, require careful design and testing to ensure that patients, caregivers, or healthcare providers can use them safely and effectively without additional training. The ability to assess generic DDCP HF—such as use environment, user population, and user interface—is critical to ensuring that generic versions can be substituted for their reference products.
The EC will provide guidance on designing research and developing methodologies that assess the comparability of DDCPs. The research and methodologies developed with EC input are intended to support the generic drug industry in demonstrating equivalence from a user interface perspective, ensuring that generics meet the same standards of safety and efficacy as their reference counterparts. The committee’s immediate areas of focus will include device design features, human factors study design, labeling, and task analysis. The EC will work collaboratively with CRCG and the FDA to support generic DDCP development approaches.
Individuals with an interest in serving on the EC are invited to submit a CV and a letter of interest (LOI) by Friday, December 20, 2024, via email to info@complexgenerics.org. In the LOI, applicants should highlight their specific expertise in user interface design, human factors engineering, regulatory requirements for combination products, and/or experience with complex generic product development. CRCG seeks an EC of independent experts, each contributing as an individual rather than as a representative of an organization or company, to provide unbiased and high-quality input. Applicants will be notified of decisions by January 31, 2025.