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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)
Jennifer L Mercier
Director, Office of Program and Regulatory Operations, OND, CDER, FDA, United States
Integrated Assessment Process: ORO Regulatory Project Management Perspective
John Farley, MD, MPH
Director, Office of Infectious Diseases, OND, CDER, FDA, United States
INMAZEB Case Study: FDA Perspective
Rhonda Hearns-Stewart, MD
Senior Physician, FDA, United States
Integrated Assessment of Marketing Applications Overview
Janie Parrino, MD
Executive Director, Regulatory Affairs, Regeneron Pharmaceuticals, Inc, United States
INMAZEB Case Study: Industry Perspective
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