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Pharmacovigilance deep dive: risk minimisation measures

European Pharmaceutical Review

The sampling strategy must be supported by sound and properly cited sources whose conclusions must be presented as supportive elements in the study documents. The following four elements of sampling methodology were found to be under-documented in RMM effectiveness studies: Supporting documentation for country/region selection.

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STAT+: FDA authorizes many AI devices for use in kids. Are they validated in a pediatric population?

STAT

But with little financial incentive for companies to develop kid-specific treatments, pediatricians are often left to use adult medicines and medical devices off-label for their patients — or none at all.  Children aren’t just little adults, goes the saying in pediatrics.