The U.S. FDA and biopharma industry experts gathered this week in Silver Spring, MD, to discuss how the FDA assesses the benefits and risks of new drugs from the preclinical to post market phases. The meeting was conducted as part of FDA preparations in drafting new guidance in FY 2020 on the benefit-risk assessment of new drugs and biologics. Theresa Mullin, associate director for strategic initiatives at the FDA’s CDER, explained how the guidance will be an “articulation of our decision-making context” for benefit-risk assessments “throughout the lifecycle of a medical product.” She said the guidance will provide information to help companies communicate and submit data to FDA. Learn More