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PDUFA V New Molecular Entity Program: History, Implementation and Future of the Program

Track:
Regulatory Affairs and Submissions

Day & Time:
June 17, 8:00AM - 9:30AM (Pacific Standard Time)

Session Number:
213

Room Number:
8

Level:
Intermediate

Type:
Session

Title:
PDUFA V New Molecular Entity Program: History, Implementation and Future of the Program

Chair(s):
Brian Michael Mayhew, MBA
Director, Regulatory Policy
Novartis Pharmaceuticals Corporation, United States

Description:
The key component of PDUFA V is the New Molecular Entity Review Program (the Program). This session will provide a background on the Program, including key elements, how it came to be, and why. This session will also provide an implementation update from FDA, including a discussion of milestones achieved thus far and those still to come. An industry representative will discuss their perspective on the implementation of the program via a business case. Lastly, the panel and the audience will engage in a discussion of what could be included in subsequent PDUFA reauthorizations.

Learning Objective(s):
Discuss background information and key elements of the New Molecular Entity Review Program including why was it established and how it works; Describe FDA's implementation of the program to date; Identify key issues that may be considered to improve the program.

Presentation(s) & Speaker(s):
Status Update: An FDA Perspective
Beth Duvall
Associate Director for Regulatory Affairs, OND, CDER
FDA, United States

Industry Perspective
Deepika Jalota, PharmD
Director, Global Regulatory Strategy, Ophthalmology/Dermatology
Bayer HealthCare, United States

Panelist
Kate Rawson
Senior Editor
The RPM Report: Regulation Policy and Market Success, United States