Joint draft guidance from two centers at the US Food and Drug Administration (FDA) outlines ways sponsors can measure pediatric growth consistently in clinical trials for drugs used to treat both rare and common diseases.
“If an investigational drug or biological product may affect growth or pubertal development, then accurate, serial measurement and recording of growth parameters are essential for data interpretation in pediatric clinical trials,” the agency announced in a pre-publication notice in the 31 October Federal Register. FDA further noted that “identifying the onset and progression of puberty are essential for accurate interpretation of growth data.” The guidance is expected to appear on 1 November.
The guidance, issued jointly by the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER), does not address drugs used to treat growth deficiencies, precocious puberty or delayed puberty…
