DIA 48th Annual Meeting
Click here to go to the previous page
Analysis and Impact of PDUFA V: How the Changes Will Affect the Work of Regulatory Affairs Professionals
Track
:
Track 08: Regulatory Affairs and Submissions
Program Code:
161
Date:
Monday, June 25, 2012
Time:
3:30 PM to 5:00 PM
EST
CHAIR
:
Janet Jenkins-Showalter, Genentech, A Member of the Roche Group, United States
PRESENTER
(S):
Andrew Emmett, The Biotechnology Industry Organization (BIO), United States
Robert Meyer, Merck Sharp & Dohme Corp., United States Beth Duvall, FDA, United States
Description
The PDUFA V agreement will become effective on October 1, 2012. Prescription drug regulatory professionals need to understand the rationale for changes, their impact, and how to use the new framework toward achieving more first cycle approvals.
Learning Objectives:
Interpret PDUFA V negotiation process/rationale for changes
Identify key changes from PDUFA IV to V
Manage communication with FDA and increase possibility of first cycle approvals.
Learning Objectives:
Interpret PDUFA V negotiation process/rationale for changes
Identify key changes from PDUFA IV to V
Manage communication with FDA and increase possibility of first cycle approvals.
This session is a part of:
Handout Online
