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Office of Orphan Products Development, U.S. Food and Drug Administration

Contact Information

Information
5600 Fishers Lane
Room 15A08
Rockville, MD 20857

800-300-7469 (Voice - Toll-free)
301-827-3666 (Voice)

Internet Resources

www.fda.gov/orphan/index.htm

Abstract

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.

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Notes

Audit

Date Entered: 7/1/1997
Date Edited: 9/21/2004
Date Revised: 1/3/2002
Health Referral Number: HR2105
Accession Number: DP91A0729

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