FDA Draft Guidance to Help Pediatric Drug Developers

Drug developers pursuing new medicines for children should establish a common scientific approach in the planning stages when navigating rules of multiple regulatory agencies, draft guidance released Nov. 21 said.

The Food and Drug Administration issued E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population, which was prepared by the International Council for Harmonisation. The ICH, of which the FDA is a founding member, aims to standardize guidelines on drug development. The draft guidance builds on a guideline the ICH developed in 2000 that addresses pediatric drug development more broadly.

“Pediatric drug development ...