FDA's Orphan Designation Backlog Plan Focuses On Efficiency, Not Staff
No additional hiring is expected as US agency announces formal plan to return orphan review times to the original 90-day goal.
You may also be interested in...
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.
Lack of information may mean FDA cannot conduct a thorough review, but HHS argues that products usually are very early in development and therefore don't have a regulatory history to document.
Janet Maynard will become acting Office of Orphan Products Development director at the end of October, the fourth head of the office in the last 10 months; staff is expected to grow and may begin to provide development advice.