The Development of Therapeutics for the Treatment and Prevention of CMV Disease in the Transplant Population: A Regulatory Perspective.
review · Level V
Where this comes from
- Record sourced from PubMed, PMID 32134476.
- Also identified by DOI 10.1093/infdis/jiz389 and PMC identifier 7057783.
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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.
Medical subject headings
- Cytomegalovirus
- Cytomegalovirus Infections
- Organ Transplantation