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.

Moderator: Martin Shimer, II, RPh
Executive Director, Lachman Consultants

Janie Gwinn
Vice President, Regulatory Affairs, Amneal Pharmaceuticals

Christina Mazzella, MSc
VP Quality Compliance, Teva Pharmaceuticals

Adam Steinberg, PharmD
Associate Director, Regulatory Affairs, Apotex

CDR Emily Thakur, RPh
Team Leader, Drug Shortage Staff, OCD, CDER, FDA

CDR Silvia Wanis, PharmD, MS, BCPPS
Senior Regulatory Officer, Incidents, Recalls and Shortages Branch, Office of Drug Security, Integrity, and Response (ODSIR), OC, CDER, Food and Drug Administration