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Phase IV Trials Mandated by FDAAA<br><i>With Great Power Comes Great Responsibility</i>
Registration
Audio CD/Transcript - March 4, 2010 <p>
The Audio CD/Transcript will be shipped the week of March 29, 2010.
</p>
$327.00
Audio CD/Transcript - March 4, 2010 <p>
The Audio CD/Transcript will be shipped the week of March 29, 2010.
</p>
$327.00
When
Event Description
First, complying with these new requirements will not be easy — because there is no one-size-fits-all guidance to help a particular drug or drug class prepare for the studies. Even the FDA admits it lacks the expertise to design the studies … so it will turn to its advisory committees to address the particulars of each product and make specific recommendations.