FDA awards 15 grants to stimulate drug, device development for rare diseases

The U.S. Food and Drug Administration today announced it has awarded 15 grants totaling more than $14 million to boost the development of products for patients with rare diseases.

 

The Orphan Drug Act was passed in 1983 to stimulate the development of products to treat rare diseases and conditions. For drugs, a disease or condition is considered rare if it affects less than 200,000 persons in the United States. For medical devices, a disease or condition is considered rare when it occurs so infrequently in the United States that there is no reasonable expectation that a medical device for such disease or condition will be developed without assistance. There are about 6,800 rare diseases and conditions, according to the National Institutes of Health. In total, nearly 30 million Americans suffer from at least one rare disease.

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http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm371503.htm