www.fdanews.com/articles/142898-fda-pilots-risk-benefit-framework-in-six-nme-applications
FDA Pilots Risk-Benefit Framework in Six NME Applications
January 4, 2012
The FDA is using a decisionmaking matrix to weigh expected clinical benefits for biopharmaceuticals against their risks in a pilot program using six NME applications under review.
Washington Drug Letter
Washington Drug Letter