Pediatric Developmental Safety Assessment: Are We Ready for the Next Thalidomide?

Pediatric drug development has achieved remarkable success in the last 20 years with over 1,000 products studied in pediatric patients. This success has been driven in part by an increased understanding of pediatric disease processes. The aspect that has been largely overlooked is the potential adverse effect of new drugs on pediatric developmental processes. The realization of this risk comes with the understanding that we could not predict another thalidomide worldwide tragedy even 70 years later.