The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment or prevention of cytomegalovirus (CMV) disease in patients who have undergone solid organ (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 biologics to support an indication for the treatment or prevention of CMV disease in post-transplant populations. This draft guidance is intended to serve as a focus for continued discussions among the Division of Antiviral Products (DAVP), pharmaceutical sponsors, the academic community, and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 the prevention or treatment of congenital CMV infection or CMV infection in patients other than those undergoing SOT or HSCT.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.