In Pharmaceutical Executive: Ron Lanton on the FDA’s Changing Clinical Trial Framework
Ron Lanton discusses the FDA’s evolving approach to clinical trial evidence and what the agency’s shift away from the traditional two-trial expectation could mean for drug development.
he FDA recently signaled a shift away from the long-standing expectation that new drugs demonstrate effectiveness through two pivotal trials.
The agency’s updated approach to clinical trial evidence could have implications for sponsors navigating regulatory approval pathways.
In this brief update, Ron Lanton walks through what the FDA announced and how the agency is thinking about trial requirements moving forward.
@Pharmaceutical Executive
https://www.pharmexec.com/shorts/fda-drops-two-trial-rule-new-drugs