Learning Tracks

GDUFA III: What’s New, What Will it Mean for Industry, and an Update on FDA’s Implementation Plan

Monday, November 7, 2022

1:30 p.m. - 3:30 p.m.

Looking to get up to speed on GDUFA III? The FDA, AAM, and industry will discuss what’s new in GDUFA III, the agreement’s associated timelines, and key messages and content published in the commitment letter. FDA staff will provide presentations, touching on an overview of GDUFDA III, operations, legislation and policy, as well as meetings on generics.

Moderator: David Gaugh, RPh
Executive Vice President, Sciences and Regulatory Affairs

Ashley Boam, MSBE

Office Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER, FDA

Jason Crawford
Senior Project Manager, Office of Program and Regulatory Operations (OPRO), OPQ, CDER, FDA

Kristin Davis, JD
Director, Office of Generic Drug Policy, OGD, CDER FDA

Kiran Krishnan, PhD
Senior Vice President, Global Regulatory Affairs, Apotex Corp.

Brian McCormick, JD
Vice President, Chief Regulatory Counsel & Head, Global Regulatory Policy, Teva Pharmaceuticals

Tawni Schwemer
Acting Associate Director for Regulatory Affairs, Immediate Office, OGD, CDER, FDA

Edward “Ted” Sherwood
Director, Office or Regulatory Operations (ORO), OGD, CDER, FDA

Molly Ventrelli
Senior Vice President, Regulatory Affairs, Fresenius Kabi USA

Lei Zhang, PhD
Deputy Director, ORS, OGD, CDER, FDA