As part of its ongoing effort to support the development of orphan products, the Food and Drug Administration (FDA) announced the availability of research grants for up to $400,000 per year for FY 2010 and FY 2011. These grants are available to support clinical research programs for drugs, biologics, medical devices (including diagnostics), and foods for medical purposes that are indicated for a disease or condition that affects fewer than 200,000 people in the United States, and for which no current therapy exists or the proposed product will be superior to the existing product. A diagnostic or a vaccine will qualify for orphan status if the U.S. population to which it will be administered is no more than 200,000 people per year.

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