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Wednesday, June 21 • 4:00pm - 5:15pm
#372: The Reauthorization of GDUFA and Its Impact on Sponsor and Regulator

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Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

GDUFA II creates a new program to support development of complex generic products including development meetings, pre-filing meetings and mid-cycle communications. This session will look at the details of the draft commitment letter and the future environment for complex generics.

Learning Objectives

Discuss what’s new in GDUFA II and the impact on sponsors and regulators.


Linda F. Bowen


Complex Generics: How Pre-ANDA Interactions with the Office of Generic Drugs Work
Robert A. Lionberger, PhD

GDUFA II and Regulatory Science Initiatives: Pre-ANDA Program for Complex Generic Drugs
Scott D Tomsky, MS

Industry Perspective
Keith Webber, PhD

avatar for Linda Bowen

Linda Bowen

Senior Director, Global Regulatory Science and Policy, Sanofi
Linda is Senior Director, Global Regulatory Science and Policy at Sanofi, and has held senior positions at Bayer and Block Drug/GSK, with global regulatory responsibilities for submissions, LCM and due diligence. She is an adjunct professor in the Temple University RA/QA Program... Read More →

avatar for Robert Lionberger

Robert Lionberger

Director, Office of Research and Standards, Office of Generic Drugs, CDER, FDA
Robert Lionberger, Ph.D. serves as Director of the Office of Research and Standards (ORS) in the Office of Generic Drugs (OGD). Dr. Lionberger leads OGD’s implementation of the GDUFA science and research commitments including internal research activities and external research grants... Read More →
avatar for Scott Tomsky

Scott Tomsky

Vice President, Regulatory Affairs, Generics, North America, Teva Pharmaceuticals
Scott D. Tomsky is Vice President, Regulatory Affairs, Generics, North America at Teva. He has been actively involved in the pharmaceutical industry for more than 20 years. Scott has held various positions in R&D, Quality Control and Regulatory Affairs at Johnson and Johnson, Ranbaxy... Read More →

Keith Webber

Sr. Dir. Rx Regulatory Affairs, Perrigo Company plc
Keith Webber is Senior Director of Rx Regulatory Affairs at Perrigo Company. Prior to joining industry, he served at the US FDA in both the CDER and CBER in a variety of roles including Director of the Office of Pharmaceutical Science, Director of the Office of Generic Drugs, Director... Read More →

Wednesday June 21, 2017 4:00pm - 5:15pm CDT
N229 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  05: Regulatory, Session