A US Food and Drug Administration perspective on evaluating medical products for Ebola

Clin Trials. 2016 Feb;13(1):105-9. doi: 10.1177/1740774515620613. Epub 2016 Jan 14.

Authors

Estelle Russek-Cohen¹, Daniel Rubin², Dionne Price², Wellington Sun³, Edward Cox², Luciana Borio⁴

Affiliations

¹ Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA estelle.russek-cohen@fda.hhs.gov.
² Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
³ Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
⁴ Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD, USA.

PMID: 26768565
DOI: 10.1177/1740774515620613

No abstract available

Keywords: Ebola; Therapeutic clinical trials; vaccine clinical trials.

MeSH terms

Africa, Western / epidemiology
Antiviral Agents / therapeutic use*
Clinical Trials as Topic / methods*
Clinical Trials as Topic / standards
Drug Approval / methods*
Drug Approval / organization & administration
Ebola Vaccines*
Hemorrhagic Fever, Ebola / drug therapy*
Hemorrhagic Fever, Ebola / epidemiology
Hemorrhagic Fever, Ebola / prevention & control*
Humans
Research Design
United States
United States Food and Drug Administration*

Substances

Antiviral Agents
Ebola Vaccines