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Steven Grossman
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Mark---I agree that enforcement actions are likely to increase across the board and that caution is advisable. However, I am not sure this can be inferred from press releases or enforcement actions in the first half of 2009. As you note, much of the staff work started in 2008 or earlier. Other items have waited for someone (anyone) to be in charge. Altogether, there is a backlog of policy and enforcement decisions. I have explored the consequences of this at: This is likely to skew comparisons for at least the first six months of Dr. Hamburg's tenure. Perhaps, this is reason for even more caution by industry...until the nature and direction of FDA leadership becomes clearer. Thanks, Steven
Toggle Commented Jul 14, 2009 on Does the FDA Have More to Talk About? at Eye on FDA