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  4. Development Considerations of Antifungal Drugs to Address Unmet Medical Need - 08/04/2020 - 08/04/2020
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Workshop

Event Title
Development Considerations of Antifungal Drugs to Address Unmet Medical Need
August 4, 2020


Date:
August 4, 2020
Time:
9:00 AM - 5:00 PM ET

Attend

Eventbrite Link

Onsite registration will start at 8:00 AM ET

Summary

FDA is announcing a public workshop regarding the development of new therapies to address unmet medical need for the treatment of infections due to invasive molds and Candida auris.

Main Objectives

Discussions will focus on the current state and clinical trial design considerations for developing new therapies for these infections and include the following topic areas:

  • Clinical need for new antifungal drugs to address unmet medical need
  • Trial design considerations, including trial populations, endpoints, and control arm for difficult to treat invasive mold infections and Candida auris infections

Registration

Those who are interested in attending this public workshop either in-person or by web viewing must register here by August 2, 2020, midnight Eastern Time. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone. Onsite registration will begin at 8:00 AM the day of the meeting. Please plan to arrive 30 minutes prior for security processing.

Location

The workshop will be held at FDA's White Oak campus, 10903 New Hampshire Ave., Building 31 Great Room, Silver Spring, MD 20993. Entrance for the public workshop participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to Public Meetings at the FDA White Oak Campus

Please indicate if you wish to present during a public comment session, and which topic(s) you wish to address during the registration process here. We will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin and will select and notify participants by July 21, 2020. All requests to make oral presentations must be received by July 14, 2020. If selected for presentation, any presentation materials must be emailed to ONDPublicMTGSupport@fda.hhs.gov no later than July 28, 2020.

Contact

If further information is needed, please contact the OND Public Meeting Support Team at ONDPublicMTGSupport@fda.hhs.gov

Streaming Webcast

This public workshop will be available online by webcast at the following link:

https://collaboration.fda.gov/antifungaldrugs080420/
 
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Webcast Recordings

Will be posted here shortly after the conclusion of the workshop

Transcripts

Will be posted here shortly after the conclusion of the workshop

Meeting Materials

All materials, such as the agenda and final speaker slides, will be posted here as soon as they are available before and/or after the workshop. Please check this webpage periodically for updates.

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