The FDA invites applications for grant awards to support clinical trials on the safety and effectiveness of orphan products, defined as drugs, biologics, medical devices, and medical foods indicated to treat or diagnose a rare disease or condition with a prevalence of fewer than 200 000 people in the United States.
These studies are intended to provide acceptable data that will substantially contribute to the approval of new products, or new indications for already marketed products. Applications are due by April 2, 2003.
McClellan MB. Request for Grant Applications. JAMA. 2002;288(17):2112. doi:10.1001/jama.288.17.2112-JFD20011-3-1