USA – Reassessing Benefit-Risk: FDA Preps for New Guidance

US Food and Drug Administration (FDA) and pharmaceutical industry experts gathered Thursday in Silver Spring, MD, to discuss how FDA assesses the benefits and risks of new drugs from the preclinical to postmarket 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 FDA’s Center for Drug Evaluation and Research (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. And it will discuss how to more explicitly incorporate patient experience data that can be used to inform benefit-risk assessments.

Kerry Jo Lee, a medical advisor at FDA, also discussed new ideas that the agency is floating related to an updated integrated review template that FDA will use internally. She said fit-for-purpose testing is ongoing…