Diane L. Hustead, MS, is a pharmaceutical regulatory professional with over 20 years of experience. Her areas of specialty are US Regulatory Affairs, Global Chemistry Manufacturing & Controls (CMC), Global Labeling, Regulatory Operations, and Quality Auditing (Manufacturing). In her current role, she leads regulatory activities for product shortages and deletions. She has directly supported disaster recovery efforts and developed business continuity plans for large-scale disruptive events. Diane is a Director in Regulatory Affairs for Merck & Co., Inc., Kenilworth, NJ USA and the Chair of the ISPE Drug Shortages Initiative Team.