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Session Chair(s)
Mark Gaydos
Head of Labeling and Advertising & Promotion, Global Regulatory Science
Moderna, United States
Learning Objective : Discuss the types of information companies might consider communicating in the pre-approval phase; Identify the communications pros and cons in the pre-approval phase.
Speaker(s)
Enforcement Action Summary
Mark Gaydos
Moderna, United States
Head of Labeling and Advertising & Promotion, Global Regulatory Science
Emerging Communication Channels in Preapproval Communication: Does the Medium Matter?
Dennis Lawrence Nosco, PHD, RAC
Mallinckrodt, United States
Senior Director, Global Labeling, Regulatory Affairs
Impact of Caronia on Preapproval Communications
Alan R Bennett, JD
Ropes & Gray, United States
Senior Counsel
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