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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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Dr Reddy's in collaboration with SkyePharma on delivery system

Dr Reddy's in collaboration with SkyePharma on delivery system


Using two of SkyePharma's unique drug delivery systems, the UK company SkyePharma has agreed to conduct a feasibility study on an unnamed product with Dr Reddy's Laboratories of India.


The study's expenses will be covered by Dr. Reddy's, and SkyePharma will also get a "small" up-front payment, according to the two businesses. Full development activities would start later this year, they stated, if the feasibility study is successful. 


With organizations like GlaxoSmithKline, Roche, Schiele, Novartis, AstraZeneca, Nitec, and Abbott in the past, SkyePharma has collaborated on the development of both licensed pharmaceuticals as well as drugs in development that use the oral, inhalation, and topical drug delivery technologies of the UK company. 


The FDA recently requested a second clinical study to gather additional efficacy data on the bronchodilator/steroid combination found in SkyePharma's proprietary non-CFC metered-dose aerosol inhaler, which resulted in the announcement that the planned new drug application (NDA) for Flutiform in the US would be delayed.

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