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Inducing Compliance With Post-Market Studies For Drugs Under Fda’S Accelerated Approval Pathway, Liang Xu, Hui Zhao, Nicholas C. Petruzzi
Inducing Compliance With Post-Market Studies For Drugs Under Fda’S Accelerated Approval Pathway, Liang Xu, Hui Zhao, Nicholas C. Petruzzi
Department of Supply Chain Management and Analytics: Faculty and Staff Publications
Problem definition: In 1992, FDA instituted the accelerated approval pathway (AP) to allow promising drugs to enter the market based on limited evidence of efficacy, thereby permitting manufacturers to verify true clinical benefits through post-market studies. However, most postmarket studies have not been completed as promised. We address this non-compliance problem.
Academic/Practical Relevance: The prevalence of this non-compliance problem poses considerable public health risk, thus compromising the original purpose of a well-intentioned AP initiative. We provide an internally consistent and implementable solution to the problem through a comprehensive analysis of the myriad complicating factors and tradeoffs facing FDA.
Methodology: We …