Clinical trials (London, England)
Confirmatory evidence supporting single pivotal trial new drug approvals by the Food and Drug Administration, 2015 through 2023.
Carla Barile Godoy, Reshma Ramachandran, Pradyumna Sapre, Joseph S Ross
Published: 202510.1177/17407745251376620
Abstract
BACKGROUNDS/AIMS: To secure market authorization, the Food and Drug Administration requires that drug manufacturers demonstrate product safety and efficacy for an indicated use based on two adequate and well-controlled studies, known as pivotal clini…
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