As artificial intelligence continues to reshape lives and industries, regulators must ensure that innovation does not outpace oversight. After the European Medicines Agency recognized an AI-assisted pathology tool as regulatory-grade evidence, questions arise over what the US should do next. In this post, Volume XLIX staff editor David Choe examines EMA's AI Qualification Opinion and outlines potential steps the FDA can take to accelerate safe drug innovation and minimize intercontinental regulatory friction.
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