Weighing the Regulatory Climate: Qnexa and the New Approval Model
By
Laura Helbling, Michael McCaughan / Email the Authors / The RPM Report September 2010, Vol. 6, No. 8
FDA Beat / Word Count: 4176 / Article # 2010500104
Executive Summary
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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