• FDA Issues New Guidance Document Regarding Use of Bayesian Statistics in Medical Device Clinical Trials
  • February 25, 2010 | Authors: Michelle Molloy Davalos; Elaine H. Tseng
  • Law Firms: King & Spalding LLP - Washington Office; King & Spalding LLP - San Francisco Office
  • On February 8, 2010, the U.S. Food and Drug Administration (FDA) issued a new guidance document discussing the use of Bayesian statistics in medical device trials and summarizing FDA’s current thoughts on appropriate use of Bayesian methods. While the guidance does provide valuable insight, it more importantly draws attention to the challenges of using Bayesian analysis.