Orphan Products Database

The FDA’s Office of Orphan Products Development (OOPD) exists to promote the development of products aimed at the diagnosis and/or treatment of rare diseases or conditions. OOPD administers the major provisions of the Orphan Drug Act, which provides incentives for sponsors to develop products for rare diseases. In addition, OOPD administers the Orphan Products Grants Program, which provides funding for clinical research in rare diseases.

Using JSP technology and an Oracle database system, GNSI developed a web-based application that allows OOPD to store and manage data on Drugs, Biologics, and Devices under review for Orphan Products designation status. The application also allows OOPD to efficiently track grants from the initial application process over the course of several years to the last funding cycle.