Designation of orphan conditions in Europe: regulatory observations and considerations after implementation of regulation 141/2000
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DOI: 10.1080/21678707.2020.1784720
Abstract: ABSTRACT Introduction In the first 18 years of the implementation of the orphan medicinal products regulation, it has been noted that every year a steady number of orphan designations refer to new conditions, not designated… read more here.
Keywords: orphan conditions; drug development; designation orphan; regulation ... See more keywords