Podcast: Non-binding Guidance: Real-World Evidence in Drug Development and FDA Submissions
The Coronavirus (COVID-19) pandemic poses an acute health risk to the population. One key to successfully combating COVID-19 lies in clinical research. Currently, almost all major research-based pharmaceutical companies, many...more
In response to the outbreak of a pneumonia-like disease caused by coronavirus (COVID-19), Chinese regulatory authorities adopted a few emergency measures under certain “Special Review and Approval Procedures” to fast-track...more
A newly-published study has compared more than a hundred new drug marketing applications at both the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) in the period 2014-2016. The study examined the...more
The U.S. Food and Drug Administration (FDA) issued three final guidance documents on June 2, 2016, that address FDA's rules and regulations governing "expanded access" to investigational drugs. The expanded access process –...more
On October 30, 2015, the U.S. Food and Drug Administration announced that it was staying portions of its controversial Final Guidance relating to the types of studies that require compliance with Investigational New Drug...more