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FDA panel packages

This article was originally published in The Gray Sheet

Executive Summary

Comments on a draft guidance on public availability of information provided to FDA advisory committee members are due Oct. 16. Guidance details processes the Center for Devices and Radiological Health will follow to ensure panel documents are disseminated in compliance with the Federal Advisory Committee Act Sec. 10(b), and that time and resources spent reviewing, redacting and publishing the information are minimized
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