Tag: orphan drugs

July 3, 2017 Off

FDA’s new orphan drug modernization plan

By Dino Mustafić

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.