Open AccessInducing Compliance with Postmarket Studies for Drugs Under FDA’s Accelerated Approval Pathway
Author(s) -
Liang Xu,
Hui Zhao,
Nicholas C. Petruzzi
Publication year - 2020
Publication title -
manufacturing and service operations management
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 7.372
H-Index - 83
eISSN - 1526-5498
pISSN - 1523-4614
DOI - 10.1287/msom.2019.0822
Subject(s) - incentive , business , food and drug administration , compliance (psychology) , risk analysis (engineering) , stackelberg competition , public economics , marketing , economics , microeconomics , psychology , social psychology
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 effica...
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