BIO Submits Comments on ICH Guideline: E11A Pediatric Extrapolation
October 28, 2022
On October 28th, BIO submitted comments on the ICH E11A Pediatric Extrapolation Guideline as published by the Food & Drug Administration (FDA). In the comments submitted, BIO voiced appreciation for the guideline’s clear explanation for how pediatric extrapolation can be applied practically to support the safety and efficacy of a product in pediatric populations. BIO also noted agreement with the guideline’s stance that extrapolation decision-making is complex, that knowledge evolves over time, and that gaps in information at the time of the initial pediatric development plan may be addressed during the execution phase of such a plan. In addition to requesting more clarity on the types of products and modalities the recommendations contained within the guideline could apply to, BIO suggested that a discussion section regarding endpoint considerations and data presentations be added. Lastly, BIO noted that a glossary with more precise definitions would be beneficial for sponsors interpreting its recommendations.
On behalf of its member companies and organizations, the Biotechnology Innovation Organization (“BIO”) extends its appreciation to NIST for considering these comments in response to the agency’s Draft Interagency Guidance Framework for Considering…
On behalf of its member companies and organizations, the Biotechnology Innovation Organization (“BIO”) extends its appreciation to NIST for considering these comments in response to the agency’s Draft Interagency Guidance Framework for Considering…
On October 28th, BIO submitted comments on the ICH E11A Pediatric Extrapolation Guideline as published by the Food & Drug Administration (FDA). In the comments submitted, BIO voiced appreciation for the guideline’s clear explanation for how pediatric extrapolation can be applied practically to support the safety and efficacy of a product in pediatric populations. BIO also noted agreement with the guideline’s stance that extrapolation decision-making is complex, that knowledge evolves over time, and that gaps in information at the time of the initial pediatric development plan may be addressed during the execution phase of such a plan. In addition to requesting more clarity on the types of products and modalities the recommendations contained within the guideline could apply to, BIO suggested that a discussion section regarding endpoint considerations and data presentations be added. Lastly, BIO noted that a glossary with more precise definitions would be beneficial for sponsors interpreting its recommendations.