Build Flexibility into Pubertal Development Guidance: BIO

BIO, the Biotechnology Innovation Organization, says FDA should clarify flexibility around what tools may be used under an FDA draft guidance on measuring growth and evaluating pubertal development in pediatric clinical trials. In its comment letter, BIO says the draft could be interpreted to be prescriptive on which tools should be used to measure growth and development because the tools cited in the guidance may not be readily available in sites with fewer resources, especially in underserved communities.

BIO also suggests that the agency add recommendations on which timeframes offer the most meaningful data for specific growth and development measurements. And it calls for additional guidance on statistical methods for analyzing growth or pubertal development and guidance on the use of stretching versus non-stretching methods to obtain height measurements.