Michael McCaughan
If you are looking for evidence of how much the regulatory climate at the Food & Drug Administration has changed...
Weighing the Regulatory Climate: Qnexa and the New Approval Model
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If you are looking for evidence that the regulatory climate has improved at FDA since 2007, look no farther than FDA's handling of Vivus' weight loss drug Qnexa: FDA's review team was ready to take a risk on the drug despite a number of safety signals that would most likely have killed a product three years ago. But if you want to know how fundamentally the regulatory model has changed, listen to what the committee said in rejecting the application.
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