Update on GDUFA III Implementation
Wednesday, October 4, 2023
10:00 p.m. - 11:30 p.m.
How has the first year of GDUFA III improved and impacted program success? This session will provide perspectives from FDA and industry highlighting important updates on the progress and performance of FDA’s generic drugs program. This session will provide observations from the implementation of GDUFA III’s review enhancements designed to enhance approvals and improve transparency. Topics like goal date extensions, trends in late-cycle IRs, and new meeting types under GDUFA III will be discussed. Industry reps will offer case studies, perspectives on success stories, and solutions for improving communications with the Agency and streamlining development.
Speakers:
Tao Bai, PhD
Senior Advisor, Office of Bioequivalence Immediate Office, OB, OGD, CDER, FDA
Peter Capella, PhD
Division Director, Division of Immediate and Modified Release Drug Products II, OLDP, OGD, CDER, FDA
John Derstine
Senior Director, Generic Regulatory Affairs, Teva Pharmaceuticals
CAPT Craig Kiester, RPh, M.S., RAC
Division Director, Division of Regulatory & Business Process Management II, OPRO, OPQ, OGD, CDER, FDA
Kiran Krishnan, PhD
Senior Vice President, Global Regulatory Affairs, Apotex Corp.
Robert Lionberger, PhD
Director, Office of Regulatory Science, OGD, CDER, FDA
Martha Nguyen, J.D.
Division Director, OGDP, OGD, CDER, FDA
Edward (Ted) Sherwood
Director, Office of Regulatory Operations, OGD, CDER, FDA
Molly Ventrelli
Senior Vice President, Regulatory Affairs, Fresenius Kabi
Panelist:
Utpal Munshi, PhD
Division Director, Division of Bioequivalence I, OB, OGD, CDER, FDA
Moderator:
Giuseppe Randazzo
Vice President, Sciences and Regulatory Affairs, AAM
