21 September 2015 - The U.S. Food and Drug Administration today announced it has awarded 18 new research grants totaling more than $19 million to boost the development of products for patients with rare diseases, which affect the lives of nearly 30 million Americans. These new grants were awarded to principal investigators in ten states, with research spanning clinical sites domestically and internationally.

“The FDA is in a unique position to help those who suffer from rare diseases by offering important incentives to promote the development of products, one of which is our grants program,” said Gayatri R. Rao, M.D., J.D., director of the FDA’s Office of Orphan Product Development. “The grants awarded this year support much-needed research in 17 different rare diseases, many of which have little, or no, available treatment options.”

The FDA awards the grants through the Orphan Products Grants Program to encourage clinical development of drugs, biologics, medical devices, or medical foods for use in rare diseases. The grants are intended for clinical studies evaluating the safety and effectiveness of products that could either result in, or substantially contribute to, the FDA approval of products.

Since its creation in 1983, the Orphan Products Grants Program has provided more than $350 million to fund more than 570 new clinical studies and supported the marketing approval of more than 50 products.

For more details, go to: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm463539.htm