The US Food and Drug Administration’s expedited approval programs: Addressing premarket flexibility with enhanced postmarket evidence generation

Clinical Trials
Volume: 15, Number: 3 (June 2018)
http://journals.sagepub.com/toc/ctja/15/3

Rejoinder
The US Food and Drug Administration’s expedited approval programs: Addressing premarket flexibility with enhanced postmarket evidence generation
Joshua D Wallach, Joseph S Ross, Huseyin Naci
First Published June 5, 2018; pp. 243–246