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The FDA and Pharmaceutical AI: Key Points from the 2025 Draft on Model Credibility

The FDA and Pharmaceutical AI: Key Points from the 2025 Draft on Model Credibility

Pharma Digital Transformation, Pharma Digitalization

The FDA positions credibility as an indispensable condition for utilising AI in pharmaceutical regulatory decision-making, within a risk-proportionate framework that demands traceability, transparency and validation throughout the entire model lifecycle. This approach...

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