Development of methods for evaluating the impact of small design differences in the user interface of drug-device combination products on generic substitutability

The purpose of this research is to develop methods for evaluating the impact of small design differences in the user interface of generic drug-device combination products when compared to the user interface of the reference listed drug (RLD). The results obtained from this research will be used to gain a better understanding of the factors related to small design differences in the user interface that impact substitutability between generic and branded drug-device combination products in end-user groups. Some key points to consider include: • The research aims to develop methods for evaluating the impact of small design differences in the user interface of drug-device combination products. • The results will be used to gain a better understanding of the factors related to small design differences in the user interface that impact substitutability between generic and branded drug-device combination products. • The research is funded by the Food and Drug Administration. • The opportunity is open to various types of applicants, including small businesses, nonprofits, and individuals.