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Analyzing Factors Impacting Time To Full Approval Of Innovative Drugs Via An Accelerated Approval Pathway In The United States, Eleanor Panico
Analyzing Factors Impacting Time To Full Approval Of Innovative Drugs Via An Accelerated Approval Pathway In The United States, Eleanor Panico
Seton Hall University Dissertations and Theses (ETDs)
Background and purpose of study: Pharmaceutical drugs are commonly used to treat various ailments and the pharmaceutical industry is increasingly leveraging expedited pathways to market, like the FDA’s accelerated approval pathway. Thus, these pathways are becoming more prevalent and thus more scrutinized for reliability. A consequence from this increased utilization is observed variability in time to reach full approval from the point accelerated approval was received. Variables that may impact time and ability to reach full approval should be further investigated. The purpose of this study was to explore, identify and predict variables that may influence time from accelerated approval …