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Furthermore, the act permits manufacturers to say a tax credit 13 within the taxable 12 months of up to 50 p.c for expenses paid or incurred by the sponsor on human scientific trials required to obtain FDA approval ( FDA, 2017c ). These factors are inclined to substantially reduce the development costs for orphan medication in contrast with what conventional medicine value to develop ( HHS, 2016 ). Nonetheless, sponsors are required to request orphan drug designation from the FDA earlier than submitting a brand new drug software ( FDA, 2017e ).
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