McKenzie Cato

McKenzie Cato

King & Spalding

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FDA Announces Completion of AI-Assisted Scientific Review Pilot and Deployment of Agency-Wide AI-Assisted Review

On May 8, 2025, the Food and Drug Administration (FDA) announced the completion of its generative artificial intelligence (AI) pilot program for scientific reviewers. FDA Commissioner Marty Makary was quoted in the...more

5/20/2025  /  Algorithms , Artificial Intelligence , Biologics , Food and Drug Administration (FDA) , Machine Learning , Medical Devices , Pharmaceutical Industry , Prescription Drugs , Regulatory Agenda , Regulatory Requirements

FDA Issues Updated Draft Guidance on Addressing Misinformation About Medical Devices and Prescription Drugs

On July 8, 2024, the U.S. Food and Drug Administration (“FDA”) issued a new draft guidance for industry titled, Addressing Misinformation About Medical Devices and Prescription Drugs – Questions and Answers (hereafter,...more

7/15/2024  /  Advertising , Disclosure Requirements , Draft Guidance , Enforcement , False Advertising , Food and Drug Administration (FDA) , Labeling , Medical Devices , Misleading Statements , Prescription Drugs
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