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
Speakers:
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
