U.S. Department of Health and Human Services

Office of Orphan Products Development, U.S. Food and Drug Administration - OOPD/FDA

Organization URL(s)


Other Contact Information

WO32-5271 10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
1-800-300-7469 (Voice - Toll-free)
301-796-8660 (Voice)
301-847-8621 (FAX)


The FDA's Office of Orphan Products Development (OOPD) is dedicated to promoting the development of products that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions. To locate such products, the OOPD interacts with the medical and research communities, professional organizations, academia, and the pharmaceutical industry, as well as rare disease groups. The OOPD administers the major provisions of the Orphan Drug Act (ODA) which provide incentives for sponsors to develop products for rare diseases. More than 228 drugs and biological products for rare diseases have been brought to market since 1983.

Print Resources

Review Date

Monday, Oct 05, 2015