Wednesday, August 29, 2018
This quarterly review on New Drug Applications contains data for applications approved for the first time during the first quarter of 2018, which includes New Molecular Entities (NMEs) and new biologics. A total of 28 applications were approved by ...
Over the years, the Prescription Drug User Fee Act (PDUFA) has authorized the USFDA to collect user fees from industry to facilitate the review process for certain human drug applications. The fifth authorization of PDUFA (2012-2017) focused mainly ...