Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials; Draft Guidance for Industry; Availability

Issue Date: October 31, 2022
Issued by: Center for Drug Evaluation and Research,Office of New Drugs
Topic(s): Clinical – Medical, Pediatric Product Development
Status: Draft

Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials; Draft Guidance for Industry; Availability

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.

Download the Guidance Document

webmaster2026-08-05T18:55:44+00:00

ABOUT US

Avance Biosciences is a leading Contract Research Organization (CRO) and Contract Testing Organization (CTO) providing CGMP and GLP-compliant analytical and bioanalytical services to support drug development. From early discovery through clinical development and commercialization, we provide CGMP and GLP-compliant services tailored to your therapeutic modality and regulatory needs.