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On Tuesday, January 3rd, BIO submitted comments in response to the Food and Drug Administration’s (FDA) recent draft guidance containing recommendations for sponsors on monitoring growth and evaluating pubertal development in clinical trials which…
BIO and its members appreciate the opportunity to work with FDA to develop and align on approaches that are robust, practical, and expedite patient focused drug development. To further enhance the Guidance, we believe that a few areas would benefit…
On Wednesday, June 22nd, BIO submitted comments on the FDA’s Quality Metrics (QM) Reporting Program. In the comments submitted, BIO stated appreciation for FDA’s intent to support a general shift toward a risk-based approach to regulation by…
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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.