The routes to orphan drug designation--our recent experience at the FDA.
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[1] Timothy R. Coté,et al. Emergence of orphan drugs in the United States: a quantitative assessment of the first 25 years , 2010, Nature Reviews Drug Discovery.
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[1] Timothy R. Coté,et al. Emergence of orphan drugs in the United States: a quantitative assessment of the first 25 years , 2010, Nature Reviews Drug Discovery.