Learning Tracks

FDA’s Drug Shortage Staff (DSS) play a critical role at CDER to help the Agency prevent and mitigate drug shortages, working with manufacturers, facilities, and multiple entities in the drug supply chain. In this session, DSS will explore some of the ongoing reasons for drug shortages as well as new challenges to the U.S. drug supply, share how DSS works with professional organizations, patient groups, clinicians, manufacturers, and other stakeholders (e.g., DEA, CMS, EMA, and others) to address drug shortages and vulnerabilities in the supply chain. In addition, FDA’s Incidents, Recalls, and Shortages Branch (IRSB) will offer its perspective on drug shortages and provide an overview of its role as a liaison between the Office of Compliance and CDER’s Drug Shortage Staff to help address drug shortage situations. Lastly, this session also will explore what actions industry can take to help prevent and mitigate drug shortages from a science and regulatory perspective.