Cytomegalovirus in Transplantation: Developing Drugs to Treat or Prevent Disease May 2018
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Drug Evaluation and Research
[Updated 5/7/2020 - FINAL]
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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2018-D-1711.