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U.S. Department of Health and Human Services

About FDA

FY 2010 "Do a Designation" Workshop

Description: The purpose of the workshops is to directly facilitate the development of Orphan Drug designation applications. Two workshops will be held: one in California in February 2010 and the other in Minnesota in August 2010. Both workshops are co-sponsored with academia and patient organizations. FDA staff will be on hand at these workshops to answer questions as applicants construct their applications.

Accomplishment: In co-sponsoring the workshops, OOPD was successful in meeting its goal to increase the number of promising applications for orphan drug status by offering detailed explanations and hands-on guidance to academic researchers, small biotechnology companies, pharmaceutical firms and other potential drug sponsors. 65 sponsor groups and an estimated 101 participants joined the workshops which were specifically designed to help simplify and clarify the orphan drug designation process for those actually working on a designation application in accordance with applicable regulatory criteria. The workshops also increased the positive interactions of FDA with each of the co-sponsorship organizations that focus on rare diseases and orphan drugs as well as educating more potential drug sponsors about the designation process. As a result of this workshop, attendees submitted 44 orphan drug designation applications for review.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Meet with Co-Sponsors

11/6/2009

Completed 11/6/2009

B. Develop and disseminate Workshop Advertisement Brochure

11/10/2009

Completed 11/10/2009

C. Draft Co-Sponsorship Agreement

12/2/2009

Completed 12/2/2009

D. Obtain Co-Sponsorship Agreement signed by each party

12/30/2009

Completed 12/30/2009

E. Develop draft workshop materials (presentations, handouts)

2/10/2010

Completed 2/19/2010

F. Complete registration for February workshop

2/19/2010

Completed 2/19/2010

G. Complete all workshop materials (presentations, handouts)

2/19/2010

Completed 2/24/2010

H. Complete February workshop

2/26/2010

Completed 2/26/2010

I. Debrief with co-sponsors on February workshop

3/15/2010

Completed 3/6/2010

J. Complete February workshop evaluation

4/15/2010

Completed 3/6/2010

K. Complete registration for August workshop

7/15/2010

Completed 7/16/2010

L. Complete August workshop

8/4/2010

Completed 8/5/2010

M. Debrief with co-sponsors on August workshop

8/27/2010

Completed 8/20/2010

N. Complete August workshop evaluation

9/17/2010

Completed 8/24/2010

O. Complete final report on workshops

9/30/2010

Completed 11/4/2010

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.