received orphan-drug designation, if the drug is only approved for some uses within that disease or condition.FDA said that its regulations incentivize sponsors to continue to develop a drug for use in all persons affected by a rare disease or condition.AGG ObservationsFDA is not deterred by the 11th Circuit decision and concluded that it would stick by its interpretation of the Orphan Drug Act.Notwithstanding the Catalyst ruling, FDA intends to apply its regulations at 21 C.F.R. Part 316 more narrowly than the 11th Circuit (i.e., the agency will limit the scope of orphan drug exclusivity to the specific uses or indications in the drug approval).While FDA has clarified its position, sponsors now have alternative precedent to cite for potential challenges to this interpretation.It looks like not much has changed in FDA’s mind, so further litigation should be expected; “tomorrow, tomorrow, I love ya, tomorrow, you’re always a day away.”[1] Catalyst Pharms., Inc. vs. Becerra, 14 4th 1299 (11th Cir. 2021).[2] 88 Fed. Reg. 4086 (Jan. 24, 2023).