Proving your product is safe and effective for OTC use is essential to gain FDA approval on an Rx-to-OTC switch application. Join this webinar and gain insights on how to develop a well-executed switch strategy from experts who have worked on 85 percent of the drugs and devices that have been successfully switched! Learn about the key elements to include in your strategy, and how to assemble the necessary research and data for a positive outcome. Also, hear from representatives from Sanofi and Merck on how they achieved FDA approval on Rx-to-OTC switch applications in 2013.

Seminar Information
Seminar Date:
February 12, 2014
Webinar Objectives
  • Understand the unique studies and data sets needed to satisfy FDA requirements.
  • Learn about success criteria, the controversies associated with them, and how to improve chances of getting three years of market exclusivity.
  • Examples from studies of what switch applications have and haven't worked with FDA.
  • Lessons learned from past switches, including 2013 successful applications.
Rx-to-OTC Switch Part II: How to Successfully Make the Switch
Speaker Information
Julie Aker  [ view bio ]
David Bradford Ph.D.  [ view bio ]
David Grob   [ view bio ]
Ed Hemwall Ph.D.  [ view bio ]
Barb Kochanowski Ph.D.  [ view bio ]
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Streaming
CHPA Member Price:$199.00
Non-Member Price:$199.00