July 3, 2017
FDA’s new orphan drug modernization plan
As the the number of orphan drug designation requests has steadily increased over the past five years, the FDA has a new plan to complete reviews of all orphan drug designation requests 90 days, that are older than 120 days (the backlog) while maintaining consistent, scientifically rigorous reviews; and after 90 days, 100% of all new orphan drug designation requests will receive a response by the agency within 90 days of receipt.