FDA regulation – Medxy AI

Leucovorin for Autism Spectrum Disorder: Navigating Clinical Efficacy and Regulatory Controversy

By MedXY 01/25/2026

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 clinical trials.

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Evidence-Based Evolution: How FDA Scientists Shielded Mifepristone Regulation From Political Interference

By MedXY 01/17/2026

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 against external political pressures.

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Demographic Data Gaps in FDA Authorization of AI-Based Devices for Alzheimer’s Disease and Related Dementias

By MedXY 07/30/2025

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.