Orphan Drugs Around the World: The Regulations and Requirements You Need to Know

Posted 17 September 2014 By Meredith Brown-Tuttle, RAC

placeholder+image "Orphan drugs" are product intended for use in the treatment of a "rare" disease—those diseases that occur infrequently or rarely in the general population of a specific location. 

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Categories: Biologics and biotechnology, Drugs, Features, US, Canada, Europe, Asia, Latin America and Caribbean, Middle East, Oceania, FDA, EMA, EC, PMDA, TGA

Tags: Orphan Drugs, Orphan Disease, Orphan Drug Act, Ultra-Orphan Diseases, Orphan Drug Regulations

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