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Integrated Assessment of US Marketing Applications: A View into FDA Internal Operations
Session Chair(s)
Amy Bertha
Executive Director, Regulatory Policy and Science
Bayer, United States
We will take a deep dive into FDA’s integrated review for marketing applications from an operations perspective. We will hear about the new review templates and how FDA has changed internal processes, review content, and role responsibilities.
Learning Objective : Explain the operational and organizational changes FDA made to the New Drugs Regulatory Program to support an integrated review for marketing applications; Name the new processes and templates, and new and changing roles FDA has developed to modernize the review of marketing applications; Summarize what industry can expect through these changes and once a steady state is reached.
Speaker(s)
Integrated Assessment Process: ORO Regulatory Project Management Perspective
Jennifer L Mercier
FDA, United States
Director, Office of Program and Regulatory Operations, OND, CDER
INMAZEB Case Study: FDA Perspective
John Farley, MD, MPH
FDA, United States
Director, Office of Infectious Diseases, OND, CDER
Integrated Assessment of Marketing Applications Overview
Rhonda Hearns-Stewart, MD
FDA, United States
Associate Director, Implementation for the Integrated Assessment of Marketing Ap
INMAZEB Case Study: Industry Perspective
Janie Parrino, MD
Regeneron Pharmaceuticals, Inc, United States
Executive Director, Regulatory Affairs
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