The FDA knows more about standard criteria, per which doctors report SAEs, than the clinical trial doctors, at least seems to me. If the FDA does not follow them, it must be intentional with an agenda.
There is no single, industry-standard way of reporting adverse events in a clinical trial or a set of clinical trials. More discussion of this topic in #msg-93667623.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”
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