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PDUFA V New Molecular Entity Program: History, Implementation and Future of the Program
Session Chair(s)
Brian Mayhew, MA, MBA
Executive Director, Regulatory Policy
Novartis Pharmaceuticals Corporation, United States
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 : 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.
Speaker(s)
Status Update: An FDA Perspective
Beth Duvall Goldstein
FDA, United States
Science Policy Analyst, ONDP, OND, CDER
Industry Perspective
Deepika Jalota, PharmD
PMV Pharmaceuticals, United States
Chief Regulatory and Quality Officer
Panelist
Kate Rawson
The RPM Report: Regulation Policy and Market Success, United States
Senior Editor
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