FDA grants to stimulate drug and device development for rare diseases

The US Food and Drug Administration yesterday announced it has awarded 15 grants totaling more than $19 million to boost the development of medical device, drug, and biological products for patients with rare diseases, with at least a quarter of the funding going to studies focused solely on pediatrics.

The FDA awards grants for clinical studies on safety and/or effectiveness of products that could either result in, or substantially contribute to, approval of the products.

“The FDA is in a unique position to help those who suffer from rare diseases by offering several important incentives to promote the development of products for rare diseases, one of which is this grants program,” said Gayatri Rao, director of the FDA’s Office of Orphan Product Development, adding: “The grants awarded this year support much-needed research in difficult-to-treat diseases that have little, or no, available treatment options.”