EDDO Combination Product Control Strategies and Best Practices

Thursday, November 13, 2025

2:30 PM - 3:30 PM East Coast USA Time

Moderator(s)

Rumi Young

Director, Regulatory Policy
Novo Nordisk

Speaker(s)

Anna Karina Busch

Regulatory Affairs Specialist
Novo Nordisk
Ashley Boam (she/her/hers)

Director, Office of Policy for Pharmaceutical Quality, Center for Drug Evaluation and Research (CDER)
FDA, Maryland, United States
Susan Clemmons

Associate Director, CMC Devices
GSK
Willy Liou

Director of Regulatory Affairs
Amgen
Shruti Mistry

Assistant Director, Injection Devices Team, Center for Devices andRadiological Health (CDRH)
FDA (Virtual)

How do you demonstrate that your combination product will meet its specifications in a premarket application? In this session, a panel of experts will share some challenges of developing a combination product control strategy in a pharmaceutical development framework, lifecycle management, and global trends. Highlights include specific recommendations from the FDA EDDO guidance, determining which EDDOs to place on release and/or stability testing, factors that determine effective design and/or manufacturing upstream control for EDDOs, and more.