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# Draft Guide on Drugs for Cytomegalovirus in Transplantation
- URL: https://www.fdaweb.com/draft-guide-on-drugs-for-cytomegalovirus-in-transplantation/
- Published: 2018-05-18T12:00:00.000Z
- Updated: 2026-09-15T00:06:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141476

FDA has published a [draft guidance](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM608059.pdf?ref=fdaweb.com) on “Cytomegalovirus in Transplantation: Developing Drugs to Treat or Prevent Disease.” The document provides recommendations for developing such drugs for treating patients who have undergone solid organ or hematopoietic stem cell transplantation. It addresses FDA’s current thinking on the overall development program and clinical trial designs for drugs and biologics to support an indication for treating/preventing cytomegalovirus disease. The guidance also discusses the use of cytomegalovirus viremia, measured as DNAemia in blood determined by polymerase chain reaction, as a surrogate endpoint in clinical trials.