The US Food and Drug Administration (FDA) has awarded 12 new clinical trial research grants to principal investigators from academia and industry across the country.
The grants total more than $15m over four years and are aimed at improving the development of medical products for patients with rare diseases.
They were awarded through the Orphan Products Clinical Trials Grants Program, which is funded by Congress to encourage the clinical development of drugs, biologics, medical devices and medical foods.
Furthermore, the grants are intended to contribute to the marketing approval of products to provide essential data needed for their development.
FDA Principal Deputy Commissioner Amy Abernethy said: “For more than 35 years, the FDA has been providing much-needed financial support for clinical trials of potentially life-changing treatments for patients with rare diseases.
“To date, the Orphan Products Clinical Trials Grants Program’s grants have supported research that led to the marketing approval of more than 60 treatments for rare diseases.”
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A total of 89 clinical trial grant applications were submitted to the FDA. More than 100 rare disease experts, including members of academia, reviewed and evaluated them for scientific and technical merit.
The grants will support product development to meet the needs of patients impacted by various rare diseases.
Recipients of the grants include investigators from Cincinnati Children’s Hospital Medical Center, Cumberland Pharmaceuticals, Massachusetts General Hospital, New York Medical College, and Privo Technologies.
Three-quarters (75%) of the new awards fund studies enrolling children and two-thirds (67%) of them fund clinical studies of products for use in various rare cancers.