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Warning letters, 483s, Recalls, Import Alerts, Audit observations
USFDA announced it has awarded 10 new clinical trial studies through Orphan Products Grants Program to support the development of medical products for rare diseases. The grants provide more than $27 million of funding to clinical researchers over the next four years. The awarded projects include a treatment for children with severe heart failure, an antidote for snake venom, cancer treatments. FDA had received 35 applications for the grant programme. The awardees include Mayo Clinic, Extend Biosciences Inc, Ophirex Inc, and others
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