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# Cytomegalovirus Treatment Guidance
- URL: https://www.fdaweb.com/cytomegalovirus-treatment-guidance/
- Published: 2020-05-07T12:00:00.000Z
- Updated: 2026-09-14T16:14:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146737

FDA has issued a guidance, *Cytomegalovirus in Transplantation: Developing Drugs to Treat or Prevent Disease*, to assist sponsors in the clinical development of drugs to prevent cytomegalovirus (CMV) disease in patients who have undergone solid organ transplantation or hematopoietic stem cell transplantation. The [document](https://www.fda.gov/media/112942/download?ref=fdaweb.com) addresses the agency’s current thinking about 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.

The guidance is intended to facilitate continued discussions among the FDA Division of Antiviral Products, pharmaceutical sponsors, the academic community, and the public, the agency says.