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Regulatory policy & guidance

Regulatory & Conduct

Three Guidance Events in One Week Redraw the Statistical Rulebook

FDA's 25-year-overdue BE statistics overhaul, ICH M11's US adoption, and the MHRA's IMA proposal landed simultaneously — at a moment when none of the institutions delivering them can promise smooth implementation.

Regulatory & Conduct

ICH M11 Is Final — but the Agency That Makes It Matter Is Unsteady

CeSHarP finalization sets a decade-defining protocol standard — just as FDA generates the kind of unpredictability that makes any pre-submission agreement harder to trust.