The U.S. Food and Drug Administration (FDA) issued a draft guidance, Benefit-Risk Assessment for New Drug and Biological Products, on September 30, 2021.1 The draft guidance is groundbreaking in its articulation of a vision of drug development that many entities involved in developing innovative new drugs and biological products should review it carefully — particularly precommercial companies whose approach emphasizes efficiency and permits some residual uncertainty with respect to clinical benefits and safety issues. Continue reading
FDA Articulates High Benefit-Risk Expectations For Drug Developers
Nov 23, 2021
Posted by Sidley Austin