Shadow FDA? Researchers Are Taking Approval Matters into their Own Hands
This article was originally published in RPM Report
Executive Summary
Drug and biotech companies will face an emerging trend of outside interference on pending drug reviews at FDA. The events surrounding the final outcome of FDA's review of Bristol-Myers Squibb and Merck's diabetes drug muraglitazar (Pargluva) signal that outside medical centers and prominent researchers will voluntarily play a larger role in drug safety oversight in the future.
You may also be interested in...
Weighing the Regulatory Climate: Qnexa and the New Approval Model
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.
Weighing the Regulatory Climate: Qnexa and the New Approval Model
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.
De-Risking Headline Risk: Merck Media Strategy Helps Company Ride Out ARBITER Data
A negative, head-to-head study questioning the role of Vytorin is presented at AHA: that sounds like a replay of the ENHANCE disaster. But here's the twist: Merck shares rallied after the data were released. What changed?