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Orphan Drug Approval in the US (and some EU Comparisons): Regulatory Mechanisms for Rare Pulmonary Disorders

Karst KR.

RDD Europe 2013. Volume 1, 2013: 93-100.

Abstract:

The development of therapeutic interventions targeted to diseases or conditions that occur in small patient populations has gained increased interest in recent years. Such interest has been due, in part, to the various advantages offered under the law for such products. This article focuses on the legal issues in the US, but also notes that similar legislation affects orphan drug development in Europe. The recently increased focus on so-called “orphan drug” development, however, also raises the prospects of controversies arising from the ways in which existing regulations are interpreted. This article focuses on the legal issues in the US but notes that similar legislation affects orphan drug development in Europe.