Cytomegalovirus in Transplantation: Developing Drugs To Treat or Prevent Disease; Draft Guidance for Industry; Availability

Streszczenie

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Cytomegalovirus in Transplantation: Developing Drugs to Treat or Prevent Disease."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 development of drugs and biologics for the treatment or prevention of cytomegalovirus (CMV) disease in patients who have undergone solid organ transplantation (SOT) or hematopoietic stem cell transplantation (HSCT).