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

Nat Rev Drug Discov. 2018 Feb;17(2):79-80. doi: 10.1038/nrd.2017.231. Epub 2017 Dec 22.

Authors

Robert N Schuck¹, Michael Pacanowski¹, Janet Woodcock², Issam Zineh¹

Affiliations

¹ Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993, USA.
² Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993, USA.

PMID: 29269943
DOI: 10.1038/nrd.2017.231

No abstract available

MeSH terms

Drug Approval / legislation & jurisprudence*
Drug Development / legislation & jurisprudence*
Humans
Molecular Targeted Therapy / methods
Pharmaceutical Preparations / administration & dosage*

Substances

Pharmaceutical Preparations