Diane L. Hustead

Merck & Co., Inc.
Executive Director, Regulatory Affairs
Diane Hustead is an advanced regulatory affairs expert and drug shortage industry leader with enthusiasm and dedication to pharmaceutical manufacturing excellence. With a diverse career path and continuously increasing responsibility over her 25 years at Merck, she has developed expertise within US Regulatory Affairs, Global Labeling, Global Chemistry Manufacturing & Controls (CMC), Regulatory Operations, and Quality Auditing (Manufacturing). Diane currently leads regulatory affairs at Merck for US product shortages, discontinuations, and import/export activities. She has directly supported supply recovery efforts and developed business continuity plans for large-scale disruptive events. Additionally, she is the chair of the ISPE Drug Shortage Initiative Team.

Related Articles

Drug Shortage Prevention
iSpeak Blog
Regulators Discuss Contemporary Approaches to Drug Shortage Prevention

In September 2021, a panel of regulators representing ANSM (France), ANVISA (Brazil), FDA (US), and the WHO participated in a webinar to discuss opportunities for drug shortage prevention. The discussion was facilitated by industry leaders while industry insights were obtained through polling of the global audience.

Engage with Health Authorities to Mitigate & Prevent Drug Shortages
Special Reports
Engage with Health Authorities to Mitigate & Prevent Drug Shortages

When faced with large-scale disruptive events such as the COVID-19 pandemic, the emergency and business continuity plans of drug manufacturers and event-specific actions of health authorities may not always be sufficient to prevent shortages of critical medical products. However, early, transparent engagement with health authorities is a powerful opportunity for drug manufacturers to...