A rare disease is defined by the Orphan Drug Act as a disease or condition that impacts fewer than 200,000 people in the U.S.
There are more than 10,000 known rare diseases that affect about 1 in 10 people (or 30 million people) in the U.S.
Other countries may have their own official definitions of a rare disease. For example, the European Union defines a disease as rare when it affects fewer than 1 in 2,000 people.
GARD utilizes selection criteria to decide which rare diseases are included on the website. Criteria are based on the availability of published and curated research information from rare disease research databases. Some rare diseases may not be represented by a GARD disease page due to the limited availability of research information. To provide information for as many diseases as quickly as possible, GARD's webpages are populated with information in bulk, rather than one disease page at a time.
The information provided on this website reflects GARD's commitment to its role as a public health resource. Rare diseases found on GARD should not be used as policy statements of NCATS or the NIH and are not regulatory statements of the U.S. FDA. Learn more about Rare Diseases at FDA.
The Genetic and Rare Diseases (GARD) Information Center website is built with high-quality health information that is easy to understand.
GARD links to selected non-governmental websites. Staff decide whether to link to a given organization or resource using the following criteria as a guide:
Organizations and Resources on GARD
Website Availability and Maintenance
In addition to the criteria for websites listed above, videos should meet these guidelines: