Phase IV Trials Mandated by FDAAAWith Great Power Comes Great Responsibility

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.


Audio CD/Transcript - March 4, 2010 The Audio CD/Transcript will be shipped the week of March 29, 2010.