Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials

On 31 October 2022 the FDA published the draft guidance on measuring and recording growth and evaluating pubertal development in pediatric clinical trials for industry.

This guidance is intended to assist sponsors in monitoring growth and, when appropriate, pubertal development in clinical trials that enroll pediatric participants with rare and common diseases. This guidance provides recommendations for the most appropriate methods for measuring and recording growth and evaluating pubertal development for evaluation of safety.