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Sponsored AI AM CLAUDE, A Beginner's Guide: Learn the basics of working with AI AI AM CLAUDE, A Beginner's Guide: Learn the basics of working with AI

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Matthieu Roustit

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Review Open access Aug 2026

Redefining Regulatory Proof: The End of the Two‐Trial Paradigm

The recent decision to establish a single pivotal trial as the default evidentiary standard for Food and Drug Administration (FDA) approval marks a substantive shift in the architecture of regulatory proof. This marks a shift from replication‐based validation to a coherence‐based model of sufficiency, beyond a procedur...

Jean-Christophe Lega, Steeve Provencher, Bruno Falissard et al. · 0 citations

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