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FDA Indicates Move Towards Voluntary IRB Accreditation System

This article was originally published in The Gray Sheet

Executive Summary

FDA is expected to implement an institutional review board accreditation system that is voluntary and independent of the agency, but still under its jurisdiction, according to David Lepay, MD/PhD, acting director of the agency's Office of Clinical Science.

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Increasing savvy around cybersecurity issues is driving regulators and trade groups to update their approach to the area, speakers from the US FDA and the American Medical Association said at this week’s FDA/CMS Summit.

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