May 11, 2018

FDA’s Unified Agenda Practices Call Into Question Document’s Usefulness

From: FDA Week

Nicholas Florko

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Bruce Levinson, senior vice president of regulatory intervention at the Center for Regulatory Effectiveness, was hesitant to criticize FDA’s practices — adding that, “as a regulatory reform advocate, my first take is to be pleased,” given a number of recent changes to the unified agenda under Trump.

He noted that OMB’s Office of Information and Regulatory Affairs (OIRA), which oversees the unified agenda, sent a memo to federal agencies in March 2017 directing them to remove any items on the agenda that realistically will not be completed within 12 months.

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