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# Draft Guide on Disease Natural History Studies
- URL: https://www.fdaweb.com/draft-guide-on-disease-natural-history-studies/
- Published: 2019-03-25T12:00:00.000Z
- Updated: 2026-09-15T01:15:24.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5143689

*Federal Register* notice: FDA has made available a draft guidance “Rare Diseases: Natural History Studies for Drug Development.” The document says that a natural history study collects information about a disease’s natural history in the absence of an intervention, from the disease’s onset until either its resolution or the individual’s death. While documenting a disease’s natural history can benefit drug development, such information is usually not available or is incomplete for most rare diseases. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-03-25/pdf/2019-05655.pdf?ref=fdaweb.com).