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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)
William Chong, MD
Associate Director for Clinical Affairs, Office of Generic Drugs, CDER, FDA, United States
Panelist
Lei Zhang, PHD
Deputy Director, Office of Research & Standards, Office of Generic Drugs, CDER, FDA, United States
Panelist
Lisa Bercu, JD
Regulatory Counsel, Office of Generic Drug Policy, FDA, United States
Panelist
Ashley Boam, MS
Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER, FDA, United States
Panelist
Susan Rosencrance, PHD
Acting Director, Office of Generic Drugs, CDER, FDA, United States
Panelist
Stelios Tsinontides, PHD, MA
Office Director, OPMA, OPQ, CDER , FDA, United States
Panelist
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