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JAMA. 2002;288:2112.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

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.

Full text of the FDA request for applications is available at http://www.fda.gov/orphan/grants, or can be requested by telephone from (800) 300-7469 or (301) 827-3666 or fax (301) 827-0017. For information on how to process application forms and how to budget the grant money, contact Maura Stephanos, FDA, HFA-522, 5600 Fishers Lane, Rockville, MD 20857 or call (301) 827-7183. Regarding the qualification of studies, contact Debra Lewis, OD, . . . [Full Text of this Article]

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