FDA awards grants for rare disease research

FDA has awarded 21 new clinical trial research grants totaling more than $23 million over the next four years to boost the development of products for patients with rare diseases. The targeted diseases include amyotrophic lateral sclerosis, cystic fibrosis, and congenital muscular dystrophy. The grants are intended to encourage the clinical development of drugs, biologics, medical devices, and medical foods. “The grants awarded this year will support much-needed research in 21 different rare diseases, many of which have little, or no, available treatment options,” says Gayatri R. Rao, director of FDA’s Office of Orphan Products Development. FDA received 68 grant applications for this fiscal year. Among the research organizations that were awarded grants are Columbia University Health Sciences, Johns Hopkins University, Vanderbilt University Medical Center, TaiMed Biologics USA, and Santhera Pharmaceuticals. Since the creation of the clinical trials grant program in 1983, FDA says that approximately $370 million has been spent on financing more than 590 clinical studies.