Food and Drug Administration

Description

Development of advanced analytical methods for the characterization and comparative analysis of complex products are important for linking product attributes to safety, quality and clinical performance, which is helpful for facilitating development of generic complex products. The purpose of this study is to develop advanced analytical methods for the characterization and analysis of ferric derisomaltose which is a complex drug product. The results from this study will help the development and review of generic ferric derisomaltose.

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

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