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Update From the US FDA on Progress and Topics of Current Interest in US Biosimilar Policy, Regulation, and Outreach/Education
Session Chair(s)
Sarah Yim, MD
Director, Office of Therapeutic Biologics and Biosimilars, OND, CDER
FDA, United States
This session will include an update from members of the US FDA on progress and topics of current interest in US biosimilar policy, regulation, and outreach/education.
Learning Objective : Discuss topics of current interest in US biosimilar policy.
Speaker(s)
FDA Update
Joseph B. Franklin, JD, PHD
Verily, United States
Head of Strategic Affairs
FDA Update
Ms. Sarah Ikenberry
US FDA, United States
Associate Director, Stakeholder Engagement and Education, OTBB, CDER
FDA Update
Dr. Christopher Downey
US FDA, United States
Division Director, Pharmaceutical Manufacturing Assessment VI, OPMA, CDER