Food and Drug Administration

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's assessment of potential differences in the adhesion quality and performance of prospective generic TDS relative to their reference TDS.

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

Contact

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