OpportunityTitle: In Vitro Approaches to Evaluate and Compare the Adhesion Performance of Transdermal and Topical Delivery Systems (TDS) (U01) Clinical Trial Required
AdditionalInformationOnEligibility: Eligible OrganizationsHigher Education InstitutionsPublic/State Controlled Institutions of Higher EducationPrivate Institutions of Higher EducationThe following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education:o   Hispanic-serving Institutionso   Historically Black Colleges and Universities (HBCUs)o   Tribally Controlled Colleges and Universities (TCCUs)o   Alaska Native and Native Hawaiian Serving Institutionso   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 BusinessesFor-Profit Organizations (Other than Small Businesses)GovernmentsState GovernmentsCounty GovernmentsCity or Township GovernmentsSpecial District GovernmentsIndian/Native American Tribal Governments (Federally Recognized)Indian/Native American Tribal Governments (Other than Federally Recognized)U.S. Territory or PossessionOtherIndependent School DistrictsPublic Housing Authorities/Indian Housing AuthoritiesNative American Tribal Organizations (other than Federally recognized tribal governments)Faith-based or Community-based OrganizationsRegional OrganizationsNon-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 purpose of this funding opportunity is to support the research to develop in vitro test methods for Transdermal and Topical delivery systems (collectively, TDS) that can correlate with and be predictive of TDS adhesion performance in vivo. Differences in product design, formulation, or quality attributes between a prospective generic TDS and it reference TDS may have the potential to alter the adhesion quality or performance of the test TDS, compared to the reference TDS. The in vitro test methods to be developed are expected to be useful for the industry to evaluate potential failure modes related to TDS adhesion during the development of prospective generic TDS, and useful in FDA&apos;s assessment of potential differences in the adhesion quality and performance of prospective generic TDS relative to their reference TDS.
GrantorContactEmailDescription: shashi.malhotra@fda.hhs.gov
GrantorContactText: Shashi Malhotra &lt;br/&gt;Grants Management Specialist &lt;br/&gt;Phone 2404027592