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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)
Beth Duvall Goldstein
Science Policy Analyst, ONDP, OND, CDER, FDA, United States
Status Update: An FDA Perspective
Deepika Jalota, PHARMD
Chief Regulatory and Quality Officer, PMV Pharmaceuticals, United States
Industry Perspective
Kate Rawson
Senior Editor, The RPM Report: Regulation Policy and Market Success, United States
Panelist
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