Workshop Update: FDA OOPD has cancelled the FDA Orphan Product Designation and Grants workshop originally scheduled for, October 4, 2013, and will reschedule for a future date.
To allow security ample time to process admittance for foreign attendees, the deadline for foreign registrations is Monday, September 23. After Monday, foreign attendees may participate via webcast only.
The Food and Drug Administration’s (FDA) Office of Orphan Products Development is convening the Orphan Product Designation and Grant Workshop. This one-day workshop is intended to provide valuable information about the FDA and European Medicines Agency (EMA) Orphan Drug Designation programs, the FDA Humanitarian Use Device (HUD) Designation program, the FDA Orphan Products Grant program to participants representing pharmaceutical, biotechnology, and device companies, as well as academics.
The morning program includes two simultaneous sessions. The first will provide an overview of the FDA Orphan Drug Designation and the European Orphan Drug Designation programs while the second will provide an overview of the FDA HUD Designation Program and Pediatric Device Consortia Grant Program. Both morning sessions will also cover the Orphan Products Grant Program as they relate to drugs/biologics, and devices. Both of these morning sessions will also be available by webcast.
The afternoon session (no webcast), provides an opportunity for appropriately registered participants to have one-on-one meetings with FDA staff members onsite, to discuss the specifics on how to apply for an orphan product grant, a HUD designation, or orphan drug designation. It also provides for videoconference sessions with EMA staff representatives on EMA orphan drug designation. Participants requesting one-on-one meetings are expected to bring information for at least one candidate orphan drug or device that holds promise for the treatment of a rare disease or condition in order to discuss the processes for putting together an application. In addition, participants in the HUD or orphan drug designation one-one-one sessions are highly encouraged to come prepared with a working draft submission of their particular promising therapy in order to maximize the utility of the one-on-one meetings.