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  4. Drug Development Considerations for the Treatment of Neonatal Enterovirus Infection and Congenital Cytomegalovirus Infection--Virtual Public Workshop - 05/07/2024
  1. News & Events for Human Drugs

Public | Virtual

Event Title
Drug Development Considerations for the Treatment of Neonatal Enterovirus Infection and Congenital Cytomegalovirus Infection--Virtual Public Workshop
May 7 - 8, 2024

Scheduled
Date:
May 7 - 8, 2024
Day1:
Tue, May 07 9:00 a.m. - 05:00 p.m. ET
Day2:
Wed, May 08 9:00 a.m. - 05:00 p.m. ET

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

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

This meeting will be held in virtual format only. Register in advance for this webinar using the Zoom link. After registering, you will receive a confirmation email containing information about joining the webinar for both days of the meeting.

Event Materials

Title File Type/Size
cCMV EV Workshop Agenda pdf (224.70 KB)
FDA cCMV and EV Workshop Affiliations and Disclosures pdf (139.32 KB)
cCMV EV Workshop Transcript pdf (2.06 MB)
cCMV EV Workshop Presentation Day One pdf (11.72 MB)
cCMV EV Workshop Presentation Day Two pdf (14.96 MB)
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