As you might expect, ever since the Vioxx and Guidant issues, FDA Commissioner Andrew von Eschenbach often gets asked whether FDA has tightened its approval standards. In a column on FDA's Web site, he provides his answer: no. "FDA has not changed its philosophy or its standards for medical product approval, and is in fact engaged in a rigorous process improvement effort to make the regulatory pathway more efficient, transparent and, yes, more rapid," he writes. But, he adds, FDA realizes that no drug or medical device can ever be 100% risk-free, so the agency has put and continues to put systems in place, both at the premarket and postmarket stages, that allow it to better understand and identify the risks. Its mission, to both protect and promote the public health, and to make sure that new medical products get to the market as quickly as possible once it can be determined that they are safe and effective, remains.