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Use of Statistics to Assess Serious Adverse Events in Clinical Trials of New Drugs: Cross-Sectional Study of FDA Review Memos | Journal of General Internal Medicine | Sarah Tanveer et al. (link.springer.com)Less than half of serious adverse events analyses submitted to the FDA in 2022 as part of a successful new drug application followed the statistical preferences encouraged by the FDA. Seems like the sort of problem that should not exist anymore with AI.
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