COVID-Infected Trials: Issues Arise In US FDA Reviews, But Nothing Decisive – Yet

 
• By Michael McCaughan

Complications in analysis due to the impact of COVID on trial conduct are a common factor in two recent negative advisory committee reviews, but it is safe to say that both applications were rejected primarily for other reasons. When will COVID issues be decisive for FDA?

The COVID storm clouds that darkened clinical trials last year are now starting to rain on applications at the US FDA. (Nielsen Hobbs; the Pink Sheet | Alamy, Getty images)
The COVID storm clouds that darkened clinical trials last year are now starting to rain on applications at the US FDA. • Source: Nielsen Hobbs; the Pink Sheet | Alamy, Getty images

More from Clinical Trials

More from R&D