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Emerging Regulation, Enforcement, and Litigation Involving Ethylene Oxide, a Critical Substance for Sterilizing Medical Products...

Ethylene oxide (“EtO”), one of the most widely used and effective substances for sterilizing medical products and devices, has come under intense scrutiny by the Environmental Protection Agency (“EPA”), the Food and Drug...more

FDA Proposes Regulatory Framework for Artificial Intelligence/Machine Learning Software as a Medical Device

On April 2, 2019, the U.S. Food and Drug Administration (“FDA” or “Agency”) proposed a new regulatory framework to address the development and marketing of artificial intelligence and machine learning-based software as a...more

FDA Regulation of Cannabis

Agency Notice Touts Authority to Regulate Products Containing Cannabis and Cannabis-derived Compounds - On April 4, 2019, the U.S. Food and Drug Administration (FDA) published a notice in the Federal Register that it...more

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