The views expressed here are those of the individual authors and not necessarily those of the JSM sponsors, their officers, or their staff.
Online Program Home
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
|
|
Abstract:
|
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.
|
The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.
Back to the full JSM 2012 program
|
2012 JSM Online Program Home
For information, contact jsm@amstat.org or phone (888) 231-3473.
If you have questions about the Continuing Education program, please contact the Education Department.