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AI Safety 2026: The New Pharma Standard

AI Safety 2026: The New Pharma Standard - Regulated AI & Model Drift Monitoring AI Safety 2026: The New Pharma Standard - A comprehensive guide to regulated AI systems, model drift monitoring, and pharmaceutical compliance The pharmaceutical and medical device industries have officially moved past the "experimentation phase" of Artificial Intelligence. In boardrooms from Basel to Boston, the conversation has shifted from "Can AI help us?" to the more pressing question: "Is our AI safe, regulated, and ready for a clinical audit?" By end of 2025, the FDA had approved or cleared 1,016 medical devices using AI/ML technologies- nearly double the number from 2022. Yet regulatory scrutiny has intensified proportionally. The FDA and EMA jointly issued guiding principles in early 2026 establishing that AI governance in drug safety must be explainable, traceable, and inspection-ready -  no different from any other GxP-regulated system. This deep dive...
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FDA lists drugs with potential safety issues

FDA lists drugs with potential safety issues


A list of drugs currently being evaluated for potential safety issues by the US Food and Drug Administration (FDA) has been posted on its website. The list has been published under laws brought in last September that require the FDA to inform the public of new safety information or potential signals of serious risk.


Information is to be published each quarter detailing drugs that have been identified as having potential safety issues based on reports in the FDA’s Adverse Event Reporting System (AERS).

The list is intended to inform patients of potential safety issues and the agency has been keen to stress that there is no definite or casual relationship between the listed drugs and their risks. 

The list is part of the FDA’s goal of improving communication with patients but could cause more harm than good if incorrectly interpreted.

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