NIH Grant: Developing Methods to Evaluate Generic Drug-Device User Interface Differences

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. 

Public/State Controlled Institutions of Higher Education
Private Institutions of Higher Education
The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education:

Hispanic-serving Institutions
Historically Black Colleges and Universities (HBCUs)
Tribally Controlled Colleges and Universities (TCCUs)
Alaska Native and Native Hawaiian Serving Institutions
Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
Nonprofits Other Than Institutions of Higher Education

Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
For-Profit Organizations

Small Businesses
For-Profit Organizations (Other than Small Businesses)
Governments

State Governments
County Governments
City or Township Governments
Special District Governments
Indian/Native American Tribal Governments (Federally Recognized)
Indian/Native American Tribal Governments (Other than Federally Recognized)
U.S. Territory or Possession
Other

Independent School Districts
Public Housing Authorities/Indian Housing Authorities
Native American Tribal Organizations (other than Federally recognized tribal governments)
Faith-based or Community-based Organizations
Regional Organizations
Non-domestic (non-U.S.) Entities (Foreign Institutions)

Foreign Institutions
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the HHS Grants Policy Statement, are allowed.

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.