Posted by Michael Wonder on 29 Mar 2022
Consequences of US FDA approval decisions in high-income countries
29 March 2022 - Akhade and colleagues highlight the global consequences of approving cancer medicines on the basis of uncertain evidence through the U.S. FDA's accelerated approval pathway.
Traditionally, the concern for U.S. regulatory standards has remained inside the USA. However, Akhade and colleagues show that the consequences can be far reaching.
Their Comment has substantial implications, especially considering the nomination of a new FDA commissioner and the opportunity that this nomination brings to enforce a suitable efficacy standard.
