Under the law, application for designation as an orphan product can be made any time prior to the filing of an application for approval to market the product. All subsequent submissions to an IND should go directly to the appropriate FDA reviewing division. The number of grant awards varies each year depending on the availability of funds. On-going studies are funded first with the remainder of funds going to new studies. In recent years, OOPD has funded approximately 20-30 new awards annually.
Small businesses are encourage to apply.
Responsive applications are reviewed and evaluated for scientific and technical merit by an ad hoc panel of experts. A second level review is done by a National Advisory Council for concurrence with the recommendations made by the initial review group. Rank ordered priority scores determine final awards. To find out what designated products are, go the Orphan Product Designation page.