Patient organisations play an increasingly crucial role in the pharmaceutical sector, yet their
impact on innovation remains unexplored. We estimate the impact of patient organisations …

In response to the COVID-19 pandemic, governments directly funded vaccine research and
development (R&D), quickly leading to multiple effective vaccines and resulting in enormous …

Purpose The objective of this work is to demonstrate the relationships between the two main
processes of research and development (R&D) activities: the knowledge generation phase …

This article utilizes a political economy framework to examine how FDA regulations
impacted the US healthcare sector's ability to address COVID‐19. I specifically examine the …

Regulatory review of new product innovation (NPI) has come to dominate contemporary
discourse on innovation management. However, there continue to be a lack of clarity on how …

Introduction: How the launch delay of drugs and other factors of interest can influence the
length of the review period by drug agencies is still unknown, and understanding this can …

With fewer than 10% of new drugs reaching the market, the drug development process is
notorious for its high attrition rate. However, we rarely observe the reason for a drug's …

Objective Regulatory use of real-world evidence (RWE) has been recognized as a useful
supplement to clinical trial evidence and could benefit patients by reducing time to treatment …

It is challenging to elucidate the effects of changes in external influences (such as economic
or policy) on the rate of US drug approvals. Here, a novel approach—termed the …

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 …