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McCormick Place

Jun 18, 2017 8:30 AM - Jun 22, 2017 12:45 PM

2301 South Martin Luther King Jr. Drive, Gate 4, Chicago, IL 60616

DIA 2017 Annual Meeting

The Reauthorization of GDUFA and Its Impact on Sponsor and Regulator

Session Chair(s)

Linda  Bowen, MSc, RAC

Linda Bowen, MSc, RAC

Assistant Adjunct Temple University

Temple University Pharmacy School, United States

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

Speaker(s)

Robert A. Lionberger, PhD

Complex Generics: How Pre-ANDA Interactions with the Office of Generic Drugs Work

Robert A. Lionberger, PhD

FDA, United States

Director, Office of Research and Standards, Office of Generic Drugs, CDER

Scott David Tomsky, MS

GDUFA II and Regulatory Science Initiatives: Pre-ANDA Program for Complex Generic Drugs

Scott David Tomsky, MS

Organon, United States

Associate Vice President, Regultory CMC

Keith  Webber, PhD

Industry Perspective

Keith Webber, PhD

Perrigo Company plc, United States

Sr. Dir. Rx Regulatory Affairs

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