FDA Holds To Its Longstanding Interpretation Of Orphan Drug Exclusivity

FDA on Monday (Jan. 23) announced that it will continue applying orphan drug exclusivity to indications or uses of a drug, rather than to entire diseases, despite a September 2021 appeals court ruling that said the law prevents FDA from approving a drug designated for the same rare disease or condition as a previously approved orphan drug even if the approvals are for separate indications or populations within the same disease. At the same time, the agency is rescinding its...