The FDA Office of Orphan Products Development's (OOPD) mission is to assist and encourage the identification, development, and availability of safe and effective products for people with rare diseases/disorders. The OOPD administers the major provisions of the Orphan Drug Act (ODA) which provide incentives for sponsors to develop products for rare diseases, usually defined as affecting fewer than 200,000 people in the United States.
The Orphan Products Grants Program in OOPD, with an annual budget of approximately $14 million, supports clinical development of products including drugs, biologics, medical devices, and medical foods for use in rare diseases and conditions where no current therapy exists or where the proposed product will be superior to the existing therapy. This program provides grants for clinical studies on safety and/or effectiveness that will either result in, or substantially contribute to, market approval of these products. In addition, OOPD will administer a new grant program, the Pediatric Device Consortia Grant Program, resulting from the 2007 FDAAA legislation, with an annual budget of $2 million to support nonprofit consortia to facilitate pediatric medical device development. Further details about both of these grants programs, go to the following page: Developing Product for Rare Diseases & Conditions.