Session: Plenary 5: Center Updates

Live Q&A (P5)

Wednesday, September 29, 2021

11:03 – 11:15 EDT

The global regulatory landscape is evolving, and innovative approaches to product life cycle and quality paradigms are met by new real-life challenges and complexities every day – patient-individualized medicines, supply challenges for legacy products, transition to new technologies, highly globalized supply chains. How will U.S. FDA continue to optimize its mission to safeguard the quality, safety, and effectiveness of medicines for patients even with these manufacturing and supply challenges? After introductory presentations, your questions on these and other issues will be posed to FDA executive management from various FDA Centers! In a virtual round table format, the conversation will focus on these issues that are often cross-cutting across different centers and relevant to the entire pharmaceutical space.

Moderator(s)

Susan J. Schniepp

Distinguished Fellow
Regulatory Compliance Associates Inc.
Las Vegas, Nevada, United States

Regulatory Panelist(s)

Matthew A. Lucia, DVM

Director, Office of New Animal Drug Evaluation, CVM
U.S. FDA
Rockville, Maryland, United States
Peter W. Marks, MD, PhD

Director, CBER
U.S. FDA
Silver Spring, Maryland, United States
Judith A. McMeekin, PharmD

Associate Commissioner for Regulatory Affairs, ORA
U.S. FDA
Silver Spring, Maryland, United States
Douglas R. Throckmorton, MD

Deputy Director of Regulatory Programs, CDER
U.S. FDA
Silver Spring, Maryland, United States