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. • Source: Nielsen Hobbs; the Pink Sheet | Alamy, Getty images
The US Food & Drug Administration’s two most recent advisory committee reviews have had more in common than meets the eye.
