The Inside Track to Orphan Drug Designation - Webinar CD/Transcript
The Inside Track to Orphan Drug Designation
Does the ODD process have you confused?
It has certainly confused many drug manufacturers. Only 480 out of 566 applications received orphan drug designation last year.
What can you do to not become a member of the group of “86”? Who is the logical person to go to?
A bit of insider knowledge might come in handy.
And who has better insider experience than the man who actually administered the Orphan Drug Act? Dr. Timothy Coté — former Director of the FDA Office of Orphan Products Development (OOPD) — will explain the ins and outs of obtaining orphan drug status.
During this session you’ll learn:
- The differences in obtaining approval for orphan vs. non-orphan drugs
- Detail prevalent criteria for orphan drugs
- The clinical superiority in orphan drug designation
- What is a “typical orphan drug”
Order today and learn how to obtain orphan drug designation from an industry insider.