Cytomegalovirus in Transplantation: Developing Drugs To Treat or Prevent Disease; Final Guidance for Industry; Availability

Streszczenie

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Cytomegalovirus in Transplantation: Developing Drugs to Treat or Prevent Disease." The purpose of this guidance is to assist sponsors in all phases of the clinical development of drugs and biological products to treat or prevent cytomegalovirus (CMV) disease in patients who have undergone solid organ transplantation (SOT) or hematopoietic stem cell transplantation (HSCT). This guidance finalizes the draft guidance of the same name issued on May 21, 2018.