Table of Contents
The List
Goals
Why does FDA publish the List?
Section 505A(b) directs FDA to:
Experts in Pediatric Research
Development of the List
Development of the List
How many drugs are there in the Orange Book?
How many drugs in the Orange Book have patent or exclusivity protection?
Publication of the List
What is the List?
What is an “approved drug” for purposes of the List?
What is an active moiety?
What does the List look like?
PPT Slide
Introduction to the List
Priority Section of the List
PPT Slide
PPT Slide
How many drugs are on the priority section of the List?
How is the priority section of the list arranged?
Therapeutic Classes
What is the difference between the priority section and the rest of the list?
Being on the List does NOT mean:
How does FDA update the list?
What issues has FDA had to clarify?
What issues related to the List does FDA anticipate taking to AC?
Summary
Additional Information
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