Background Over the past decades, US Congress enabled the US Food and Drug
Administration (FDA) to facilitate and expedite drug development for serious conditions …

Background: The breakthrough therapy designation (BTD) facilitates the development of
drugs with a large preliminary benefit in treating serious or life-threatening diseases. This …

Biotechnology and small pharma companies must recognize the opportunity presented by
FDA Breakthrough Therapy Designation (BTD) to expedite drug development for serious …

The Food and Drug Administration's (FDA's) breakthrough therapy designation (BTD)
program was created to increase patient access to safe and effective therapies by …

During the initial phase of the COVID-19 pandemic, the Food and Drug Administration (FDA)
halted inspections of most overseas drug manufacturing establishments. Looking at data …

This study investigates how enhanced regulation can promote innovation, focusing on the
impacts of a significant regulatory reform in China's pharmaceutical sector implemented in …

We offer new evidence on the relationship between competition and innovation that
overcomes two measurement difficulties compromising the extant literature: aggregation at …

Fast development of COVID-19 vaccines likely averted millions of deaths. We estimate how
many more lives could have been saved if safe and effective vaccines were available earlier …

Digital technologies are bringing vast improvements to modern society but also carry the risk
of perpetuating disparities if adopted at lower rates by underserved communities. We …

This study evaluates drug regulation in the United States by examining a product that was
unexpectedly judicially exempted from drug regulation in 2010: e-cigarettes. We compare …