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  • The EU AI Act and Pharma Compliance: What Life Sciences Companies Need to Know

    The EU AI Act and Pharma Compliance: What Life Sciences Companies Need to Know

    The EU AI Act is reshaping how pharmaceutical and life sciences companies develop and deploy AI — from clinical trials to diagnostics. As the world’s first comprehensive AI regulation, it introduces strict rules around risk classification, human oversight, and audit trails. If your company is building AI-powered tools or seeking approval in the EU and…

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  • FDA AI Food Safety: How ELSA is Changing Import Oversight

    FDA AI Food Safety: How ELSA is Changing Import Oversight

    Summary:FDA ELSA AI food safety efforts mark a turning point in how the agency screens food imports, using machine learning to flag high-risk shipments. In June 2025, the FDA announced the agency-wide launch of a powerful new AI tool named ELSA (Enhanced Learning and Surveillance Algorithm). Designed to improve how the FDA screens imported foods,…

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