Food and Drug Administration

Description

The goal of this project is to develop methods for evaluating the impact of differences in the design of the user interface of generic drug-device combination products in comparison to the reference listed drug (RLD). Specifically, the project should (i) investigate methods that have the potential to support the categorization of differences in the design of the user interface (minor design differences or other design differences), and (ii) explore different approaches (using in vivo and/or in vitro methods) to assess other design differences as potential alternatives to comparative use human factors (CUHF) studies. The developed methods for evaluating the impact of differences in the design of the user interface will be used by all stakeholders engaged in the development of generic drug-device combination products including regulatory agencies, the pharmaceutical industry and academia. The outcomes of this project will help improve the understanding of the factors related to design differences of the user interface that may impact substitutability between generic and RLD drug-device combination products for intended end-user groups and, thereby, support the development of generic versions of these products that can enhance and stabilize patient access to medicines they need.

Who can apply

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

Contact

Shashi Malhotra <br/>Grants Management Specialist <br/>Phone 2404027592
shashi.malhotra@fda.hhs.gov