http://www.emea.europa.eu/pdfs/general/direct/pr/55739107en.pdf
COMMON EMEA/FDA APPLICATION FORM FOR ORPHAN MEDICINAL PRODUCT DESIGNATION
http://www.emea.europa.eu/pdfs/human/comp/EMEAFDA_Application_Form_for_Orphan_Medicinal_Product_Designation.doc
Regulatory information links on new drug development ; study designing, planning and statistics
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