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Artificial Intelligence Center for Biologics Evaluation and Research (CBER) Emergency Use Authorization (EUA)

Faegre Drinker Biddle & Reath LLP

The Dawn of a New Day — FDA Bases Regulatory Decision on ML-Generated Data

The U.S. Food and Drug Administration is all about hard science, and correlation of variables is not evidence of causation. To make a regulatory decision, FDA has long held that line, requiring evidence of actual occurrences...more

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