Hypothalamic-Pituitary-Adrenal Axis Pediatric Safety Studies Submitted to the FDA.

Future pediatric drug development program goals would be to determine whether HPA axis suppression studies should be conducted, establish optimal testing methods if HPA axis testing is performed, continue to update guidances for industry, and actionable labeling recommendations. However, regulatory policy related to conducting pediatric HPA axis studies requires additional scientific research and discussion by the pediatric drug development community.