The FDA has awarded 12 new research grants that together total more than million, to enhance the development of medical products for patients with rare diseases, including acute myeloid leukemia (AML) and gastrointestinal stromal tumor (GIST), among others.1
The grants are awarded through the Congress-funded Orphan Products Clinical Trials Grants Program, which is designed to encourage clinical development of drugs, biologics, medical devices, and medical foods for the treatment of patients with rare diseases. Additionally, the grants are planned to contribute to marketing approval of products for these rare diseases or provide the necessary clinical data that are required for development of such products, the agency stated in a press release.
“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,” Amy Abernethy, MD, PhD, FDA principal deputy commissioner, stated in the press release. “We are encouraged by the amount of interest we continue to have in the grants program and are committed to working with researchers and industry to facilitate and support the study and development of treatments for patients with rare diseases.”
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