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# Draft Guide on Rare Disease Natural History Studies
- URL: https://www.fdaweb.com/draft-guide-on-rare-disease-natural-history-studies/
- Published: 2019-03-22T12:00:00.000Z
- Updated: 2026-09-15T01:15:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143677

FDA has made available a draft guide entitled “[Rare Diseases: Natural History Studies for Drug Development.” ](http://app.info.fda.gov/e/er?utm%5Fcampaign=SBIA%3A%20FDA%20Releases%20Guidance%20for%20Industry%20on%20Rare%20Diseases%3A%20Natural%20History&utm%5Fmedium=email&utm%5Fsource=Eloqua&s=2027422842&lid=7087&elqTrackId=9D9C8894B8A9C79C12C889DF077D9166&elq=18765136a4fb4430881370db29783a19&elqaid=7300&elqat=1)The document is intended to help inform the design and implementation of natural history studies that can be used to support safe and effective drug and biological product development for rare diseases. Specifically, it describes the broad potential uses of a natural history study in all phases of drug development. It also covers the strengths and weaknesses of various types of natural history study designs, common data elements and research plans, and a practical framework for the conduct of a natural history study.