FDA Takes a Stand on Orphan Drug Exclusivity in Unusual FR Notice
The FDA has been walking a thin line on orphan drug exclusivity (ODE) ever since a September 30, 2021, ruling by the U.S. Court of Appeals for the Eleventh Circuit issued a decision in Catalyst Pharms., Inc. v. Becerra (Catalyst), 14 F.4th 1299 (11th Cir. 2021). in the pre-publication of today’s Federal Register, the FDA […]