"Over the past several months, FDA has emphasized science and getting tough." The agency is also conveying the notion "that FDA is not just the primary arbiter, but the sole arbiter of what is good science."

— Nancy Buc, former chief counsel of FDA and a current partner at Buc & Beardsley, challenging FDA's belief that med tech businesses cannot ever be counted on to provide good science in their clinical trials, "Ex-FDAer: agency thinks that industry's views are 'tainted.' "