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FDA Orphan Drug Workshop

Worried about creating an orphan drug designation application?

Then you’re not alone, typically submissions to the FDA evoke considerable consternation among drug sponsors. This workshop is designed to make the process of orphan drug development transparent and accessible to those uninitiated in regulatory affairs.

How do I register?

Prospective participants should send to CDR Lucienne Nelson at 301-827-3666 or lucienne.nelson@fda.hhs.gov  the following information:
•Names of proposed attendees
•Contact information
•Desired workshop location
•Proposed orphan product for which an application will be developed
•Proposed rare diseases for said product

FDA will keep product and disease information provided confidential. Acceptance at each workshop will be limited to no more than three participants who attend in support of each of the first 50 product proposals.

For more information click here. 

 

College of Pharmacy
University of Minnesota
Minneapolis, Minnesota
August 3-4, 2010

Sponsored by the Office of Orphan Products Development, Food and Drug Administration