Setting The Sights on Science

Andy von Eschenbach is doing the smart and right thing by reaching to a group of academics and industry researchers to see if the FDA's science is up to snuff. It sets the stage for future collaborations and funding requests. Asking Gail Cassell, who was on my FDA Task Force when I was at the Manhattan Institute, to chair this group signals that the FDA is serious. Dr. Cassell is brilliant, well-respected and has taken on a similar task with respect to biodefense issues. What's more, she provides badly needed support to Janet Woodcock to make the review staff at the agency more Critical Path conscious. Look for an overhaul and upgrade of folks who do not want to embrace biomarkers, adaptive trials, Bayesian analyses, etc.

PS...Jacob Goldstein's health blog at wsj.com is great....

http://blogs.wsj.com/health/2007/05/01/fda-science-under-the-microscope/