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# FDA Rare Disease Natural History Study Grants
- URL: https://www.fdaweb.com/fda-rare-disease-natural-history-study-grants/
- Published: 2016-02-29T12:00:00.000Z
- Updated: 2026-09-15T02:39:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134907

> FDA has made available $2 million in research grants to fund natural history studies in rare diseases. “The goal of the program is to help characterize the natural history of rare diseases, identify subpopulations, and develop and/or validate clinical outcome measures, biomarkers and companion diagnostics,” an [FDA notice](http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm488016.htm?ref=fdaweb.com) says. “Natural history is the course a disease takes in affected individuals from the time immediately prior to its inception, progressing through a presymptomatic phase and different clinical stages, to a final outcome in the absence of treatment. This type of information is often not available, or incomplete, for many rare diseases.”  
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> FDA says that not understanding how a rare disease progresses can slow medical product development. “Information about a disease’s natural history can aid in clinical trial design, identify study end points and lead to faster, better trials – hopefully leading to new and effective diagnostics and treatments,” it says.  
>  
> Grant applications will be due 10/14, and the agency says all submissions applications will be reviewed and evaluated for scientific and technical merit by a panel of rare disease and natural history experts.