FDA awards grants for Clinical Trials on Rare Diseases
The U.S Food and Drug Administration on October 8, 2019, announced a total of 12 new grants amounting to a total of more than $15 million which will be distributed over the next 4 years to perform the Clinical Trials on Rare diseases. The grant will be used to facilitate the clinical development of drugs, biologics, medical devices and medical foods for the treatment of rare diseases that include Duchenne Muscular Dystrophy, sickle cell disease, Fanconi anemia and some others. These grants were awarded to the principal investigators from academics and industry across the country through the Orphan Products ClinicalTrials Grants Program of FDA.
These approved grants are mainly focused on the advancement of the product development to meet the need of patients suffering from various rare diseases, with emphasis on those affecting children and cancers. These newly awarded grants are intended to accelerate the clinical approval of products for effective and efficient treatment of rare diseases as well as to provide essential clinical data for the development of thee products.
In a total, FDA received 89 clinical trial grant applications for review and evaluation by more than 100 scientific experts from industry and academia fraternity. In a total of 12 awarded grants, more than half of the awards will be focusing on the study of targeting a variety of rare diseases affecting children and having a high risk of life-threatening conditions. whereas, two-thirds of the new awards are expected to fund clinical studies of medical products involving in treatment of various rare cancers such as genetically engineered virus therapy and novel drug delivery system, which, ultimately may eliminate current barriers to drug delivery that patients come across during treatment.
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