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Session 3: Impact of US FDA Final Naming Guidance for Biologics
Session Chair(s)
Hillel P Cohen, PHD
Biosimilars Expert, Retired, United States
In January 2017, the FDA issued a Final Guidance on the naming of biologics, including originator biologic medicines and biosimilars. The FDA is developing plans to roll out this new naming convention both prospectively and retrospectively. Likewise, numerous stakeholders throughout the US health care system have already or will adapt their current processes to accommodate the Final Guidance. This session will explore considerations for implementing the new system and provide an overview of some of these plans.
Learning Objective :
Speaker(s)
Kellie Taylor
Associate Director, OMEPRM, OSE, CDER, FDA, FDA, United States
Speaker
Thomas Felix, MD
Medical Director, R&D Policy, Global Regulatory Affairs and Safety, Amgen Inc., United States
Speaker
Tammy P Powell, MLIS, MS
Health Program Specialist, National Library of Medicine, United States
Speaker
Gerald McEvoy, PHARMD
Assistant Vice President of Drug Information, American Society of Health-System Pharmacists, United States
Speaker