Regulatory policy for the development of targeted therapies for low-frequency molecular subtypes of disease

Nature Reviews Drug Discovery 17, 79 (2018). doi:10.1038/nrd.2017.231 Authors: Robert N. Schuck, Michael Pacanowski, Janet Woodcock & Issam Zineh Numerous challenges arise when developing targeted therapies for diseases comprising low-frequency molecular subtypes. In this article, we describe a pragmatic, science-based regulatory policy for the development and approval of targeted therapies in such cases.
Source: Nature Reviews Drug Discovery - Category: Drugs & Pharmacology Authors: Tags: Comment Source Type: research