Scout | R01 Clinical Trials for Rare Neurodegenerative Diseases with Unmet Needs (New Indication/Label Changes)

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R01 Clinical Trials for Rare Neurodegenerative Diseases with Unmet Needs (New Indication/Label Changes)

This opportunity supports FDA-focused clinical trials to test the efficacy and/or safety of products aimed at a new indication or label change for rare neurodegenerative diseases affecting children and adults. It emphasizes collaborative, efficient, and innovative trial designs to help increase approved treatments in this area. The notice is specific to R01 clinical trials required to meet the…

Source

Agency: Food and Drug Administration

Award

Award Ceiling: $900,000

Award Floor: $650,000

Eligibility

government

nonprofit

small_business

tribal

university

For profit organizations other than small businesses

Native American tribal governments (Federally recognized)

Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education

Private institutions of higher education

State governments

Keywords

r01

clinical trials

rare neurodegenerative

unmet needs

new indication

label change

fda

pediatric-adult

Supporting Links

Documents

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