Navigating Combination Product Pathways: Industry Experiences and FDA’s Role

Depending on the primary mode of action (drug, device or biologic) a combination product is assigned to an FDA center (CDER, CBER and CDRH) for premarket review and regulation. FDA’s Office of Combination Product provides guidance to industry in the process but there are also Center liaisons known as product jurisdiction officers that play a role in combination product designation and policy.   For these products, industry experts will share real-world experiences and best practices associated with FDA engagement pathway(s) throughout the product life cycle. The roles of FDA jurisdiction officers play in the inter-center consult request (ICCR), policies and regulatory decision making will be explored.

Moderators

• Chin-Wei Soo, Global Regulatory Head – CMC/Devices and Combination Products, Genentech
• Rumi Young, Director, Regulatory Policy, BD

Speakers

• Chelsea O’Connell, Director, Global & Regulatory and R&D Policy at Amgen
• Kristina Lauritsen, Combination Product Policy Advisor, Center for Drug Evaluation and Research (CDER) FDA
• Sarah Mollo, Combination Products Analyst, Center for Devices and Radiological Health (CDRH), FDA
• Winifred Wu, President and Principal Advisor, Strategic Regulatory Partners, LLC