Rare Pediatric Disease Voucher Program Gains Temporary Extension From House Committee
US incentive program would gain only four more years, despite calls for a permanent extension.
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In part because assessment costs plummeted in FY 2019, the FY 2021 fee to redeem a priority review voucher will be 37% less than the previous year.
US FDA received 110 designation requests in July, a high mark that reflects the 60 days needed to review such requests ahead of the 30 September statutory expiration; agency is allowing email submission of RPD and orphan drug designation requests during the COVID-19 pandemic and expects to roll out an online portal for orphan designation requests later this year.
Marinus Pharmaceuticals has transformed its finances and the prospects for its R&D pipeline over the past 12 months, and has just reported positive top-line results from the Phase III MARIGOLD study of its lead compound, ganaxolone.