Law360, New York (February 03, 2012, 1:18 PM ET) -- Over the past decade, the the U.S. Food and Drug Administration has relied on guidance rather than formal note and comment rulemaking to achieve its regulatory aims and implement congressional mandates. Stephen M. Johnson, Good Guidance Good Grief, 72 MO. L. REV.695, 695 (2007).
In fact, since the 1980s, formal regulations adopted each year under the Administrative Procedure Act have fallen over 50 percent, and the rate of informal guidance, such as interpretive rules, policy statements and guidance documents issued has risen by over 400 percent....
A Little 'Guidance': All You Need For Preemption?
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