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J Infect Dis 2020 Mar 5;221(Suppl. 1):S109-12

The development of therapeutics for the treatment and prevention of CMV disease in the transplant population: a regulatory perspective.

Hodowanec AC, Pikis A, Singer ME

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.

Category: Journal Article, Review, Regulatory
PubMed ID: #32134476 DOI: 10.1093/infdis/jiz389
Includes FDA Authors from Scientific Area(s): Drugs
Entry Created: 2020-03-08 Entry Last Modified: 2020-05-31
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