Drug Development Considerations for the Treatment of Neonatal Enterovirus Infection and Congenital Cytomegalovirus Infection--Virtual Public Workshop - 05/07/2024

DESCRIPTION AND SUMMARY The Food and Drug Administration is holding a public, two-day workshop entitled “Development of Drugs for the Treatment of Congenital Cytomegalovirus (CMV) Infection and Neonatal Enterovirus Infection.” The purpose of the public workshop is to discuss clinical trial design considerations, including endpoints, study population, and comparators, related to the development of drugs for the treatment of congenital CMV infection and neonatal enteroviral sepsis. MEETING MATERIALS All meeting materials—including agenda, panelist affiliations/disclosures, speaker slides, workshop recording, and transcript—will be posted shortly before and/or after the completion of the workshop. Please check this page regularly for updates. Transcripts of the workshop will be posted here approximately 30-45 days after the completion of the workshop. Zoom Recordings To view recordings, copy and paste the following links into a web browser Day 1 https://fda.zoomgov.com/rec/share/NmHnX6ypwL5UlG5ccQEc_SFZR9lKqb3n-vnka6_kCU1gjDbgKpE3IC8bqtVkmZMh.vbO9Pf6MZaBRpKvf Day 2 https://fda.zoomgov.com/rec/play/C6uTcvZbjgx0G-RQciALj9RACfabRGhP_dVbaahEIEH1Wfe84LCj3Je2c0ZaGP2IUws-qiYN5MCvlF6L.CHv9WU241osmpO1e ONLINE ATTENDANCE (WEBCAST) This virtual public workshop will be webcast via Zoom. You will receive a link for viewing via email, or you can check back here for the link on the day of the event. For more information about Zoom, please visit this Zoom Support Webpage. EVENT POINT OF CONTACT Antoinette Ziolkowski Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave. Bldg. 22, Room 6221 Silver Spring, MD 20993-0002 301-796-1300 REGISTRATION