Section: Wednesday, April 23, 2014; 10:30 AM - 12:00 PM | EPI 260: Development and Approval of Drugs and Devices (Spring 2014)

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Section outline

No Attendance required: What you need to file and IND/IMPD

The preclinical studies, information and the process that are required to get approval to carry out clinical studies in humans.

Faculty: Richard Chin

Location: China Basin 6702
- Select activity Session Slides:
  
  Session Slides:
- Select activity Epidemiology 260 Spring 2012
  
  Epidemiology 260 Spring 2012 File
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  Session Audio/Video Recording (Access restricted to registered students):
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  Required Reading/Viewing:
- Select activity Principles and Practice of Clinical Trial Medicine...
  
  Principles and Practice of Clinical Trial Medicine (2008), Chapter 2, pages 31-37.
- Select activity FDA website info on the IND Application
  
  FDA website info on the IND Application URL

July 2026

Section outline