Food and Drug Administration

Description

The goal of this proposal is to compare the pharmacokinetics of two sources of generic tacrolimus capsules to Prograf in stable transplant patients. Patients will be switched between both brand and generic. The outcome of this study can help address the public concerns regarding the quality of generic tacrolimus and improve review practices of generic tacrolimus if necessary.

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

Lisa Ko <br/>Grants Management Specialist
lisa.ko@fda.hhs.gov