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

Archived

Food and Drug Administration

Description

The purpose of this funding opportunity announcement (FOA) is to support clinical studies of products that address unmet needs in rare diseases or conditions or provide highly significant improvements in treatment or diagnosis. Through the support of efficient and innovative clinical studies evaluating safety and/or effectiveness, FDA expects to increase the number of treatments for rare diseases with an unmet medical need and support studies that will either result in market approval of these products or substantially contribute to the essential data needed for medical product development that will ultimately meet the needs of rare disease patients.

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

Daniel Lukash <br/>Grants Management Specialist <br/>Phone 240-402-7596
daniel.lukash@fda.hhs.gov

Key dates & funding
  • PostedOct 23, 2018
  • ClosesJun 25, 2019
  • Expected awards15
  • CFDA93.103
Categories

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