FDA’s pediatric anti-infective guidance encourages efficacy extrapolation, adolescent inclusion in adult pivotal trials

FDA’s latest pediatric guidance outlines what’s needed to extrapolate efficacy of anti-infective drugs from adults to children, and sends a clear message that adult trials should include patients aged 12 and up whenever possible.

Because anti-infectives target microbes instead of host biology, they are overwhelmingly likely to have similar effects in adults and children. ...