In the fall of 1960, a newly hired pharmacologist named Frances Kelsey received her first assignment at the FDA: review a drug called Kevadon [1]. It was, by all appearances, a routine case. The drug was already sold across Europe and Canada, prescribed to pregnant women to ease morning sickness. The manufacturer’s application was thick …

Continue reading “RWE: From Regulatory Footnote to the Future of Medical Affairs, Part 1.”