Jaenisch, Muraru, and Pandey discuss how regulators will audit pharma against its own AI policies and ways QA and regulatory teams can build defensible, inspection-ready AI practices.
News|Videos|October 16, 2026
PharmTech AI Pulse Check: Why Pharma Should Weigh In on FDA's Generative AI Paper
The deadline to comment on FDA's generative AI paper is Oct 19, 2026. We explain why professionals in pharma manufacturing should weigh in.
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FDA’s discussion paper on generative AI for medical devices has opened a public comment period running through October 19, 2026, and the panelists on PharmTech AI Pulse Check argue that the industry’s response will matter well beyond device regulation. Richard Jaenisch, Florin Muraru, and Gourav Pandey walk through what they expect commenters to raise, and why pharma manufacturing, quality, and regulatory professionals, not just device makers, have a stake in how the conversation lands.
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