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Abstract Details

Activity Number: 554
Type: Topic Contributed
Date/Time: Wednesday, August 1, 2012 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #305381
Title: Codevelopment of Two Unmarketed Investigational Drugs: FDA Guidance and Experiences
Author(s): Wen Zeng*+ and Greg (Guoxing) Soon
Companies: FDA and FDA
Address: 10903 New Hampshire Avenue, Silver Spring, MD, 20993, United States
Keywords: Codevelopment ; FDA Guidance ; Review Experience

A Combination drug development has become more common clinical practice for some hard-to-treat disease areas. In this talk, we will discuss FDA newly published Guidance for industry codevelopment of two or more unmarketed investigational drugs for use in combination and some review experiences in the antiviral disease area during the clinical trial development stage.

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