From Harbor-UCLA Medical Center, Center for Clinical Pharmacology, Torrance, California (Dr Brass), and University of Colorado, School of Medicine, Division of Cardiology, and CPC Clinical Research, Aurora, Colorado (Dr Hiatt). Submitted for publication February 15, 2011; revised version accepted May 1, 2011. Address for correspondence: Eric P. Brass, MD, PhD, Harbor-UCLA Center for Clinical Pharmacology, 1124 W Carson St, Torrance, CA 90274; e-mail: [email protected].
The authors thank Dr Allison Goldfine for her helpful comments on the manuscript.
Financial disclosure: Both Drs Brass and Hiatt have served as Special Government Employees for the FDA, but the opinions expressed here are their own. Drs Brass and Hiatt serve as consultants to a number of pharmaceutical companies with interests in the FDA's regulatory process. Dr Brass holds equity in Calistoga Pharmaceuticals and Catabasis Pharmaceuticals. Dr Hiatt is president of CPC Clinical Research, an Academic Research Organization affiliate of the University of Colorado that performs contract research for the pharmaceutical industry.
