Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) Clinical Trials Required

Archived

Food and Drug Administration

Description

The purpose of this funding opportunity announcement (FOA) is to fund clinical trials of products evaluating efficacy and/or safety in support of a new indication or change in labeling to address unmet needs in rare diseases or conditions. Additionally, through the funding of collaborative, efficient, and/or innovative clinical trials, FDA expects to increase the number of approved treatments for rare diseases and exert a broad and positive impact on rare disease drug development.

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

Key dates & funding
  • PostedJul 5, 2022
  • ClosesOct 30, 2024
  • Award floor$200,000
  • Award ceiling$650,000
  • Expected awards20
  • CFDA93.103

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