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This cross-sectional study examines US Food and Drug Administration regulatory review time of supplemental new indication approvals of drugs and biologics between 2017 and 2019.
Conflict of Interest Disclosures: Ms Dhodapkar reported receiving a Ruth Jackson Orthopaedic Society Annual Meeting Medical Student Scholarship outside the submitted work. Ms Dhodapkar also reported serving as the associate editor of visual abstracts for the North American Spine Society Journal. Dr Ross reported receiving grants from the US Food and Drug Administration (FDA), Johnson & Johnson, the Medical Devices Innovation Consortium, the Agency for Healthcare Research and Quality, and the National Heart, Lung, and Blood Institute outside the submitted work. Dr Ross also reported serving as an expert witness at the request of the relator’s attorneys, the Greene Law Firm, in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen, Inc that was settled in September 2022. Dr Ramachandran reported receiving grants from the Laura and John Arnold Foundation, the Stavros Niarchos Foundation, and the FDA during the conduct of the study and consulting fees outside the submitted work from the ReAct–Action on Antibiotic Resistance Strategic Policy Program at Johns Hopkins Bloomberg School of Public Health, which is funded by the Swedish International Development Cooperation Agency. Dr Ramachandran also reported serving as unpaid chair of the FDA Task Force of Doctors for America and as board president of Universities Allied for Essential Medicines North America.
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