Seminar: Inducing Compliance with Post-Market Studies for Drugs under FDA’s Accelerated Approval Pathway
In 1992, FDA instituted the accelerated approval pathway (AP) to allow promising drugs to enter the market based on limited evidence, but requiring manufacturers to verify the drugs’ true clinical benefits through post-market studies. However, most post-market studies are not completed due to many incentive issues, and FDA must endure an onerous process to withdraw an unproven drug from the market when a post-market study is uncompleted.