Inducing compliance with postmarket studies for drugs under FDA's accelerated approval pathway

• Main Authors: XU, Liang, ZHAO, Hui, PETRUZZI, Nicholas C.
• Format: text
• Language: English
• Published: Institutional Knowledge at Singapore Management University 2021
• Subjects: health public policy; drug approval policy; pharmaceutical industry; asymmetric information; moral hazard; Chemicals and Drugs; Operations and Supply Chain Management
• Online Access: https://ink.library.smu.edu.sg/lkcsb_research/7082; https://ink.library.smu.edu.sg/context/lkcsb_research/article/8081/viewcontent/Inducing_Compliance_with_Postmarket_Studies_for_Drugs_Under_FDA_av.pdf
• Institution: Singapore Management University

Problem definition: In 1992, the Food and Drug Administration (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 postmarket studies. Howev...