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Office of Generic Drugs and Office of Pharmaceutical Quality Generics Town Hall
Session Chair(s)
Rachel Turow, JD, MPH
Of Counsel, FDA Regulatory
Skadden, United States
Hear from leadership in FDA's Office of Generic Drugs and Office of Pharmaceutical Quality about key priorities and topics of interest for generic drug development.
Learning Objective : Identify top policy issues for generic drug development; Discuss quality and inspectional challenges for generic pharmaceutical products; Identify regulatory issues and opportunities specific to complex generics.
Speaker(s)
Panelist
William Chong, MD
FDA, United States
Associate Director for Clinical Affairs, Office of Generic Drugs, CDER
Panelist
Lei Zhang, PHD
FDA, United States
Deputy Director, Office of Research & Standards, Office of Generic Drugs, CDER
Panelist
Lisa Bercu, JD
FDA, United States
Regulatory Counsel, Office of Generic Drug Policy
Panelist
Ashley Boam, MS
FDA, United States
Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER
Panelist
Susan Rosencrance, PHD
FDA, United States
Acting Director, Office of Generic Drugs, CDER
Panelist
Stelios Tsinontides, PHD, MA
FDA, United States
Office Director, OPMA, OPQ, CDER