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FDA: Orphan Drug Workshops Scheduled For Feb. 25-26 and Aug. 3-4, 2010
Date:12/23/2009

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

During the past 25 years, the FDA has granted orphan drug designation to about 2,100 drugs, of which 344 have become approved products.

For more information:

Do a Designation: FDA Orphan Drug Workshops

http://www.fda.gov/downloads/ForIndustry/DevelopingProductsforRareDiseasesConditions/UCM189586.pdf

Designating an Orphan Product: Drugs and Biologics

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


    Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov
    Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration


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