The Development of Therapeutics for the Treatment and Prevention of CMV Disease in the Transplant Population: A Regulatory Perspective-Reference-Cited by-同舟云学术

The Development of Therapeutics for the Treatment and Prevention of CMV Disease in the Transplant Population: A Regulatory Perspective

Published:2020-03-05 Issue:Supplement_1 Volume:221 Page:S109-S112
ISSN:0022-1899
Container-title:The Journal of Infectious Diseases
language:en
Short-container-title:

Author:

Hodowanec Aimee C¹,Pikis Andreas¹,Singer Mary E¹

Affiliation:

1. Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Office of Infectious Diseases, Division of Antiviral, Silver Spring, Maryland

Abstract

Abstract Cytomegalovirus (CMV) remains an important pathogen in the transplant population. As such, the US Food and Drug Administration has published a guidance to encourage and inform the development of therapeutics for the treatment and prevention of CMV disease in this population. This review summarizes important phase 3 trial design considerations for industry and provides rationale for some of the recommendations included in the guidance.

Funder

National Institute of Allergy and Infectious Diseases

National Institute of Child Health and Human Development

Publisher

Oxford University Press (OUP)

Subject

Infectious Diseases,Immunology and Allergy

Link

http://academic.oup.com/jid/article-pdf/221/Supplement_1/S109/32791266/jiz389.pdf

Reference22 articles.

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2. The association between cytomegalovirus infection and atherosclerotic events in renal transplant recipients;Ozdemir;Transplant Proc,2007