Janelle Derbis, PharmD, is a Director in Regulatory Affairs at Merck (Rahway, NJ), responsible for leading regulatory activities for product shortages and deletions in the US and serves as a subject matter expert on various FDA and other health authority regulations. Prior to joining Merck, Janelle worked for the U.S. Food and Drug Administration (FDA) for over 20 years within the Office of the Commissioner and CDER’s Office of the Center Director. Throughout her FDA career, she led complex drug safety projects and assisted in the planning, development, and evaluation of FDA policies related to health professional and patient advocacy organizations. Additionally, she is a member of the ISPE Drug Shortage Initiative Team.