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

Food and Drug Administration · Opportunity FOR-FD-20-013

Who can apply

• State governments
• County governments
• City or township governments
• Special district governments
• Independent school districts
• Public and State institutions of higher education
• Native American tribal governments (Federally recognized)
• Public housing authorities
• Native American tribal organizations (other)
• Nonprofits with 501(c)(3), other than higher education
• Nonprofits without 501(c)(3)
• Private institutions of higher education
• Individuals
• For-profit organizations other than small businesses
• Small businesses

About this opportunity

The purpose of the 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.

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