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**IMPORTANT**

The information contained in the Organizational Database (ODB) is provided for informational purposes only. There is no implied endorsement by NORD. NORD does not promote or endorse participation in any specific organization. The information is subject to change without notice. Every effort is made to ensure that the details for each entry are as current as possible.

Food and Drug Administration (FDA) Office of Orphan Products Development

Address

10903 New Hamphire Avenue
WO 32-5271
Silver Springs, MD 20993

Phone

301-796-8660

Fax

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800 Number

800-300-7469

TDD

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Email Address

Jeff.Fritsch@fda.hhs.gov

Website

http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/default.htm

The Food and Drug Administration has charged The Office of Orphan Products Development (OOPD) to dedicate its mission to promoting the development of products that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions. In fulfilling that task, OOPD interacts with the medical and research communities, professional organizations, academia, governmental agencies, 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. The ODA has been very successful - more than 200 drugs and biological products for rare diseases have been brought to market since 1983. In contrast, the decade prior to 1983 saw fewer than ten such products come to market.

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