Back to Agenda
Session 7: Combination Products and Medical Device Labeling
Session Chair(s)
Su-Yueh Lin
Sr. Labeling Consultant, Regulatory Affairs
SYL Regulatory Consulting, Taiwan
The labeling for drug-device combination products - drugs that are combined with device-based delivery systems - continues to evolve as a topic of interest for the industry. This session will discuss the current guidance and regulations for combination product labeling in the US and EU. Useful information on combination product labeling development from conceptualization to agency approval will be provided from industry and regulator perspectives. The regulatory experience for a recently FDA-approved combination product involving mobile app will also be presented.
Learning Objective : At the conclusion of this session, participants should be able to:- Describe the latest information regarding the current regulations and guidance for combination product labeling in US and EU
- Identify best practices when developing labeling for a drug-device combination product
- Gain latest knowledge on the technology and regulatory pathway for incorporating mobile app in a combination product
Speaker(s)
Current Regulations and Guidance and a Process Overview for Developing the Labeling for a Drug-Device Combination Product
Ryan McGowan
AstraZeneca, United States
Associate Director, Combination Products
Human Factors and Labeling/IFU Development
James Meehan
AstraZeneca, United Kingdom
Associate Principal Scientist – Human Factors
Case Study: Regulatory Experience for a Drug-Device Combination Product Involving a Mobile App
Michael Fahmy, MS
Otsuka Pharmacutical Development & Commercialization, Inc., United States
Senior Director, Global Regulatory Affairs
Have an account?