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When PDUFA II decreased the requisite amount of Period III clinical trials for approval from two to at least one, this codified a practice presently in position at FDA; informal guidelines permitted only one demo being accepted sometimes.31 Nevertheless, the elevation of single-trial permissibility to statue marked a decline in the number of new medication nonetheless adhering to the two-demo common. Top nearly PDUFA II’s passage in 1995–1997, eighty one% of recent ps slot 24 medicine were supported by two pivotal trials.32 This proportion declined to fifty three% by 2015–2017, at the same time as the standard of pivotal trials has also declined, in phrase of an elevated use of placebo controls (rather then active comparators) and solitary-arm patterns.
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