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Session 9: Digital Health: Challenges and Opportunities for Labeling with Drug Companion Apps
Session Chair(s)
Bill Zeruld
Business Development - Digital Strategy
Otsuka America Pharmaceuticals, Inc., United States
As digital technologies become even more ubiquitous in our everyday lives, life science companies are increasingly offering digital apps as companions to their prescription drug products. These apps, while having the potential to improve the patient experience with their medications, also present numerous regulatory questions and challenges.
Learning Objective : At the conclusion of this session, participants should be able to:- Describe what a prescription drug companion app is and provide examples of existing systems
- Discuss FDA’s communications to date regarding prescription drug companion apps
- Identify potential implications for industry and regulators given the identified regulatory challenges
Speaker(s)
Opportunities and Challenges for the Digital Product Evolution
Darin Seth Oppenheimer, DrSc
Merck & Co., Inc., United States
Executive Director, Device & Digital Health Solutions
Digital Health: Challenges and Opportunities for Labeling with Drug Companion Apps – CDRH Perspective
James P. Bertram, PhD, MS, RAC
FDA, United States
Director, Office of Combination Products, OC
Digital Health: Challenges and Opportunities for Labeling with Drug Companion Apps – CDER Perspective
Kristina Lauritsen, PhD
FDA, United States
Combination Products Regulatory Policy Advisor, OEP, CDER
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