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

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

This grant opportunity supports clinical trials for rare neurodegenerative diseases that currently lack adequate treatment options. The trials should focus on assessing the safety and effectiveness of medical products to either introduce a new usage or modify existing labeling. The FDA encourages using innovative trial designs to speed up drug development.

Source

Agency: Food and Drug Administration

Dates

Opportunity Released: August 14, 2024

Eligibility

tribal

university

nonprofit

small_business

government

U.S. Territory or Possession

Independent School Districts

Public Housing Authorities/Indian Housing Authorities

Native American Tribal Organizations (other than Federally recognized tribal governments)

Faith-based or Community-based Organizations

Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Organizations)

Non-domestic (non-U.S.) components of U.S. Organizations

Private Institutions of Higher Education

Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations (Other than Small Businesses)

Special District Governments

Keywords

rare diseases

clinical trials

orphan products

neurodegenerative diseases

unmet needs

product development

medical products

drug development

innovative trial designs

FDA

Supporting Links

Documents

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