OpportunityTitle: Development of Methods to Evaluate the Impact of Design Differences to the User Interface of Generic Drug-Device Combination Products in Comparison to their Reference Listed Drugs (U01) Clinical Trials Optional
AdditionalInformationOnEligibility: Higher Education InstitutionsPublic/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 EducationNonprofits 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 OrganizationsSmall Businesses For-Profit Organizations (Other than Small Businesses) GovernmentsState 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 OtherIndependent 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 InstitutionsNon-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.
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.
GrantorContactEmailDescription: shashi.malhotra@fda.hhs.gov
GrantorContactText: Shashi Malhotra &lt;br/&gt;Grants Management Specialist &lt;br/&gt;Phone 2404027592