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Session 4: Words Matter: Labeling Challenges Unique to Combination Products
Session Chair(s)
Kirsten H. Paulson, MS, RAC
Pfizer, Inc., United States
Cross-labeled combination types range from companion therapeutics with diagnostic tests that must be used together, to loosely structured labeling references to use with a class of medical products. Can a new device recommend use with a marketed drug without changing the drug label? What happens when one of the cross-labeled products changes? This session will include discussion of challenges with legally labeling these related products and how to avoid pitfalls both pre and postmarket.
Speaker(s)
Heidi F. Gertner
Hogan Lovells US LLP, United States
Partner
Speaker
Ryan McGowan
AstraZeneca, United States
Associate Director, Combination Products
Speaker
Alan Stevens, MS
FDA, United States
Acting Division Director, Division of Drug Delivery, General Hospital and Human