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Orphan Drug Development Guidebook – START Checklist

This online guide provides a framework for researchers to help navigate orphan drug development offering detailed charts of the regulatory processes in Europe, the US, and Japan. ‘Building block’ fact sheets summarise key concepts, organizations, and tools involved in drug development. Milestones show the stages a project needs to reach with checklists for what to do before and after each milestone. This video ( introduces the guide in detail and has a helpful walkthrough of the website starting at 50.46.

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