Regulatory watch: Why do oncology drugs fail to gain US regulatory approval?

Nat Rev Drug Discov. 2015 Jul;14(7):450-1. doi: 10.1038/nrd4651. Epub 2015 May 22.

Authors

Sean Khozin¹, Ke Liu², Jonathan P Jarow¹, Richard Pazdur¹

Affiliations

¹ Center for Drug Evaluation and Research, Silver Spring, Maryland 20993, USA.
² Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993, USA.

PMID: 26000722
DOI: 10.1038/nrd4651

No abstract available

Publication types

News

MeSH terms

Animals
Antineoplastic Agents / therapeutic use*
Drug Approval / legislation & jurisprudence*
Drugs, Investigational / therapeutic use*
Humans
Neoplasms / drug therapy*
Neoplasms / epidemiology
United States / epidemiology
United States Food and Drug Administration / legislation & jurisprudence*

Substances

Antineoplastic Agents
Drugs, Investigational