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Clinical Trials Addressing Unmet Needs of Rare Neurodegenerative Diseases (R01) Clinical Trials Required

Food and Drug Administration

Deadline: TBD

Summary

The grant aims to fund clinical trials evaluating the efficacy and safety of products for new indications or labeling changes to address unmet needs in rare neurodegenerative diseases, ultimately increasing the number of approved treatments. Eligible applicants include government entities, nonprofits, educational institutions, small businesses, and for-profit organizations. Application details are not provided, but interested parties can contact the grantor via email at terrin.brown@fda.hhs.gov for more information.

Full description

Description

The purpose 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 neurodegenerative diseases for children and adults. Through the support of collaborative, efficient, and/or innovative clinical trials, FDA expects to increase the number of approved treatments for rare neurodegenerative diseases and exert a broad and positive impact on rare disease drug development.

Eligibility

Eligible applicants

Government

  • Special district governments
  • Public and Indian housing authorities
  • State governments
  • Federally recognized Native American tribal governments
  • City or township governments
  • County governments

Nonprofit

  • Nonprofits non-higher education with 501(c)(3)
  • Other Native American tribal organizations
  • Nonprofits non-higher education without 501(c)(3)

Education

  • Public and state institutions of higher education
  • Independent school districts
  • Private institutions of higher education

Miscellaneous

  • Unrestricted

Business

  • Small businesses
  • For-profit organizations other than small businesses

Additional information

Grantor contact information

Description

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Email

terrin.brown@fda.hhs.gov

terrin.brown@fda.hhs.gov

Apply on official siteUpdated Oct 30, 2025

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