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When PDUFA II diminished the requisite quantity of Section III clinical trials for acceptance from two to one, this codified a follow already in place at FDA; informal rules permitted a single trial being accepted in some instances.31 However, the elevation of single-trial permissibility to statue marked a decrease in the quantity of new drugs even now adhering to The 2-demo standard. Top approximately PDUFA II’s passage in 1995–1997, 81% of latest prescription drugs had been supported by two pivotal trials.32 This proportion declined to 53% by 2015–2017, whilst the caliber of pivotal trials has also declined, in expression of an elevated usage of placebo controls (rather than active comparators) and single-arm types.
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PDUFA V will pgufa24 deliver with the ongoing well timed assessment of new drug and biologic license applications. More details on PDUFA V
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