Flexibility in the FDA approach to orphan drug development

Nature Reviews Drug Discovery 16, 737 (2017). doi:10.1038/nrd.2017.151 Authors: Nina L. Hunter, Gayatri R. Rao & Rachel E. Sherman Scientific advances, in combination with government incentives and commercial opportunity, have fuelled strong investment in orphan drugs, resulting in many innovative therapies. Here, we discuss the approach of the FDA to a range of issues that remain crucial to maintaining this momentum, such as the use of the totality of evidence in evaluating orphan drugs.
Source: Nature Reviews Drug Discovery - Category: Drugs & Pharmacology Authors: Tags: Comment Source Type: research