FDAnews
www.fdanews.com/articles/137942-fda-to-begin-benefit-risk-assessment-pilot-for-drug-reviews

FDA to Begin Benefit-Risk Assessment Pilot for Drug Reviews

June 27, 2011
The FDA plans to begin a pilot program putting a new benefit-risk framework to use in drug reviews as part of its efforts to bring more structure to the assessment system, an FDA official says.
Drug Industry Daily