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Since 1983, greater than 600 medication and biological merchandise have been dropped at market with the act's help ( FDA, 2017e ). Fewer than 10 such industry-sponsored products entered the market in the decade preceding the act ( FDA, 2017e ). Over the past 5 years, orphan drug approvals have elevated exponentially ( Consider Pharma, 2017 ). In 2016, practically half of the brand new medicines accepted had been orphan medicine, including two which can be indicated for diseases with no approved treatments ( FDA, 2017e ).
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