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Download Polar Regions

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  • create individualized orphan product strategies that include guidance on regulatory strategy and feasibility of drug development, scientific review of proposed drug repurposing plans, evaluation of clinical study design, and trouble-shooting regulatory and development issues
  • author and review applications for orphan drug designations, pediatric rare disease designation vouchers, breakthrough therapy designations, and other expedited review applications
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  • interpret policies and communications from regulatory agencies around the world
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