Orphan Drug Designation: Meeting the Unmet Need in Rare Diseases
April 26, 2018 - Online ON CAXtalks
fbonilla@xtalks.com
Phone: 416.977.6555
Join this 1-hour webinar where the audience will gain a practical overview of the steps to achieve orphan status including: Review of the Orphan Drug Designation eligibility criteria, including a registered medicine with a new ‘orphan indication’ An overview of Orphan Drug Designation incentives, such as tax, marketing approval and market exclusivity Practical application, process and insights EU & FDA requirements and assessing the differences
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