In Pharmaceutical Executive: Ron Lanton on the FDA’s Changing Clinical Trial Framework

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