FDA Risk Evaluation Workshop Announced

The Food and Drug Administration (FDA) announced a public workshop entitled “Risk Evaluation and Mitigation Strategy Assessments: Social Science Methodologies to Assess Goals Related to Knowledge.”

The purpose of the public workshop is to initiate constructive dialogue and information-sharing among regulators, researchers, the pharmaceutical industry, health care organizations, health care providers, and others from the general public about survey methodologies and instruments that can be used to evaluate patients’ and health care providers’ knowledge about the risks of drugs marketed with an approved REMS.  As labeling experts, PDG can help you decide if a REMS is necessary OR address FDA requirements that you implement a REMS for your drug product.

Risk Evaluation and Mitigation Strategy Assessments Issue Paper