Methods
We merged the EMA and FDA database of approvals based on non-RCT
comparisons. We excluded duplicate entries between the two databases. We
included a total of 134 approvals of drugs and devices based on
non-RCTs. We integrated Weber-Fechner law of psychophysics and
recognition heuristics within SDT to provide descriptive explanations of
the decisions made by the FDA and EMA to approve new treatments based on
non-randomized studies without requiring further testing in RCTs.