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

About this grant

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. Grant Number: FOR-FD-25-001.

Eligibility requirements

All of the following criteria must be met:

• Check official grant listing for detailed eligibility requirements

What the funding covers

• Award Range: $650K to $900K

How to apply

1. 1Check eligibility: Confirm your organization type (e.g., nonprofit, state government), project alignment, and deadlines from the opportunity synopsis.
2. 2Register: Create a Grants.gov account via Login.gov, complete SAM.gov and UEI registration, and authorize organization representatives (takes 2-4 weeks).
3. 3Prepare application: Select "Apply" to open Workspace, download forms (e.g., SF-424), complete offline/online with validation checks, and upload supporting docs like budgets and narratives.
4. 4Submit and track: Check package for errors, sign/submit via Authorized Organization Representative (AOR), and monitor status with your tracking number
5. 5Applications must be submitted through grants.gov
6. 6Grant Number: FOR-FD-25-001
7. 7Posted: 2024-08-14

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