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DIA 2021 Global Annual Meeting


Integrated Assessment of US Marketing Applications: A View into FDA Internal Operations

Session Chair(s)

Amy  Bertha

Amy Bertha

  • Executive Director, Regulatory Policy
  • 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

Integrated Assessment Process: ORO Regulatory Project Management Perspective

Jennifer L Mercier

  • Director, Office of Regulatory Operations, OND, CDER
  • FDA, United States
John  Farley, MD, MPH

INMAZEB Case Study: FDA Perspective

John Farley, MD, MPH

  • Director, Office of Infectious Diseases, OND, CDER
  • FDA, United States
Rhonda  Hearns-Stewart, MD

Integrated Assessment of Marketing Applications Overview

Rhonda Hearns-Stewart, MD

  • Associate Director, Implementation for the Integrated Assessment of Marketing Ap
  • FDA, United States
Janie  Parrino, MD

INMAZEB Case Study: Industry Perspective

Janie Parrino, MD

  • Executive Director, Regulatory Affairs
  • Regeneron Pharmaceuticals, Inc, United States