AI in Drug Development, Biologics, and Medical Devices: Recent Signals from the FDA and EMA
Dear Clients,
We are pleased to share our client update on recent regulatory developments at the FDA and the EMA relating to the use of artificial intelligence in drug development, biologics, and medical devices.
The update outlines key signals emerging from both agencies and considers their practical implications for companies operating in these sectors, particularly those seeking to access or expand in the U.S. and European markets.
As regulatory expectations around the use, validation, documentation, and governance of AI continue to evolve, these developments are likely to be of increasing relevance to companies across the healthcare and life sciences industries.
As always, the team at Agmon with Tulchinsky remains at your disposal.
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