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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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Former Eli Lilly Senior VP-Corporate Strategy & Policy Mitchell ("Mitch") Daniels is confirmed by the Senate Jan. 24 as the next director of the Office of Management & Budget. Prior to Lilly, Daniels served a stint as a partner with the Indianapolis law firm Baker & Daniels (no relation) while serving as president of the Hudson Institute, a conservative think tank (1"The Gray Sheet" Jan. 1, 2001, p. 8)

Cybersecurity: Guidance Docs To Come, But Legacy Devices Still A Challenge

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.

Majority Of Spanish OTC Firms Investing Heavily In Digital

A recent ANEFP survey shows that the majority of Spanish OTC firms consider their digital strategies to be "very advanced."



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