Published in Gastroenterology Week, October 23rd, 2006
Orphan drug designation is intended to encourage research and development of new therapies for diseases that affect fewer than 200,000 patients in the United States. The designation also provides eligibility for a special 7-year period of market exclusivity upon approval, potential tax credits for research, grant funding for research and development, reduced filing fees for marketing applications, and assistance with the...
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