FDA Awards 21 Grants

FDA www.fda.gov awarded 21 new clinical trial research grants totaling more than $23 million for the next four years to boost the development of products for patients with rare diseases. These grants were awarded to researchers from academia and industry with research spanning domestic and international clinical sites.

FDA awarded these grants through the “Orphan Products Clinical Trials Grants Program” to encourage clinical development of drugs, biologics, medical devices, or medical foods for use in rare diseases.

Since its creation in 1983, the clinical trials grants have provided more than $370 million to fund more than 590 new clinical studies and supported the marketing approval of more than 55 products.

One of the goals of the National Cancer Moonshot Initiative is to accelerate cancer research. So 24 percent of the new clinical trials grant awards will fund studies enrolling patients with cancer along with 40 percent of the studies to target devastating forms of brain cancer.

In addition, one of the funded projects will provide the means to conduct a medical device trial to develop a fully implantable neuroprosthesis for grasp, reach, and trunk function in individuals with spinal cord injuries. This has the potential to allow patients to use their hand, arm, and trunk more independently.

The study on the medical device is being done by Case Western Reserve University. The “Phase 2 Study of a Networked Neuroprosthesis for Grasp, Reach, and Trunk Function in Cervical Spinal Cord Injury” will receive about $2 million over four years to complete the research.

fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm525468.htm for recipients for FY 2016 in the field of drugs and biologics.

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