New EMA guidance on pediatric trials, Crohn's endpoints

The European Medicines Agency released a guideline for pediatric investigation plans (PIPs), which revises its 2008 guideline specifying drug developer obligations to test new medicinal products in children. The new document provides circumstances under which parts of a PIP can be deferred until the adult studies are completed, and when adult studies don't take as long as studies in children.

The new guideline also specifies how proposals to extrapolate data from adults to children must be documented and substantiated. ...