Tutorial 1: From the Pediatric Case Files of FDA

Ever wondered why FDA granted a waiver under PREA for one product but required studies under PREA for a similar product? Join FDA for a stimulating and challenging tutorial about issues related to pediatric product development.

Cases will be presented that illustrate a variety of common and not-so-common situations that the Agency has addressed in pediatric product development since the passage of BPCA and PREA. FDA will guide the discussion but audience participation is requested!