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This article evaluates the clinical evidence supporting leucovorin for autism spectrum disorder and examines the FDA’s controversial proposal to expand its indications based on mechanistic data rather than traditional large-scale clin
A comprehensive review of over 5,000 FDA documents confirms that the agency’s regulation of mifepristone between 2011 and 2023 was driven by clinical safety data and internal scientific consensus, remaining remarkably resilient agains
Limited demographic data transparency in FDA-authorized AI devices for Alzheimer’s may hinder equitable care and generalizability, highlighting a crucial need for improved dataset representativeness and regulatory oversight.