Module232025

12/05/2025

Common Commentary

A tool to inform sponsors of products discussed at the Paediatric Cluster

SOP in place to select products for adding Commentary

Discussion points, identifying similarities and/or differences in FDA’s and EMA’s approach, are summarised in a 1-2 page document that is cleared by FDA and EMA

This document is sent to the sponsor. Comments sent are not binding on either Agency (i.e. they do not constitute regulatory advice)

The Organisation for Professionals in Regulatory Affairs

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M Dehlinger-Kremer, 14 May 2025

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Common Commentaries in Numbers

Paediatric Cluster Calls August 2019-November 2020 • 12 Cluster Calls scheduled • 17 Oncology products discussed – sponsors informed of action items • 5 Common Commentaries (bilateral non-binding advice) issued

Courtesy of Dr. Gregory Reaman, Associate Director Pediatric Oncology, FDA https://ascopubs.org/doi/10.1200/JCO.20.02152

The Organisation for Professionals in Regulatory Affairs

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M Dehlinger-Kremer, 14 May 2025

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