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FDA Schedules Third Orphan Drug Workshop for Nov. 4-5, 2010
Date:10/13/2010

gnation, the orphan drug may then be submitted for review through the FDA marketing approval process, which evaluates the drug for safety and efficacy.

Since 1983, when the Orphan Drug Act was passed, the FDA has received 3,212 applications for orphan drug designation and has granted orphan drug designation to about 2,250 drugs, of which 361 have become approved products.

For more information:

  • DIA/FDA: Orphan Drug Designation Workshop Brochure

http://www.fda.gov/downloads/ForIndustry/DevelopingProductsforRareDiseasesConditions/UCM215487.pdf

  • Developing Products for Rare Diseases and Conditions

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

  • Drug Information Association

http://www.diahome.org/DIAHome/Home.aspx

Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA


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SOURCE U.S. Food and Drug Administration
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