Issue Date: May 21, 2018
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Antimicrobial
Status: Final
Cytomegalovirus in Transplantation: Developing Drugs to Treat or Prevent Disease
The purpose of this guidance is to assist sponsors in the clinical development of drugs to treat or prevent cytomegalovirus (CMV) disease in patients who have undergone solid organ transplantation (SOT) or hematopoietic stem cell transplantation (HSCT). Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current thinking regarding the overall development program and clinical trial designs for the development of drugs and therapeutic biological products to support an indication for treating or preventing CMV disease in post-transplant populations. This guidance is intended to facilitate continued discussions among the Division of Antiviral Products (DAVP), pharmaceutical sponsors, the academic community, and the public. This guidance does not address drug development for treating or preventing congenital CMV infection or CMV infection in patients other than those undergoing SOT or HSCT.
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