Two US pharmaceutical industry groups note that they are generally supportive of the International Council for Harmonization (ICH) guideline on pediatric extrapolation in drug development but suggest that the guidance should address a broader subset of the population and not just focus on extrapolating data from adults. The groups called for more information on using biomarkers for the pediatric population and for including the estimands concept in the final guidance.
These comments were made in response to the US Food and Drug Administration (FDA) call for feedback on the ICH E11A, which was released for comment in April 2022 (RELATED: ICH drafts guideline on pediatric extrapolation in drug development, Regulatory Focus, 6 April 2022).
The guideline establishes a framework for extrapolating drug development data from adult trials to pediatric populations.
FDA received comments from the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO), as well as Otsuka Pharmaceuticals and PTC Therapeutics…
