The drug has brought relief to children suffering from cancer and other serious ailments, but getting access is often limited by considerable regulatory hurdles.
Over the past 15 years, new laws and regulations in the United States and the European Union have expanded to require the inclusion of pediatric patients in clinical drug trials.
A lot changes in a child’s body over the course of development, and not all changes occur linearly: gene expression can fluctuate, and organs can perform different functions on the way to their final purpose in the body. Here are some of the key deve