HER2-Low Project Meeting Session 1

The HER2-Low Project initial meeting session occurred on Friday, April 7, with participation from a number of experts in the field. The scoping session resulted in an overview of relevant theme (please find below). If you’d like to contribute, please reach out via email to digipathalliance@gmail.com with additional resources, or complete this survey to help us to identify the topic of most interest to pursue for a regulatory science project.

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Voices of PIcc

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FDA: CDRH Issues Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Medical Devices