- August 4, 2020
This public workshop is currently being scheduled and planned as a virtual meeting. The Food and Drug Administration is announcing a virtual public workshop to discuss unmet medical needs of invasive molds and Candida auris and clinical trial design considerations for developing new therapies.
ABOUT THE PUBLIC WORKSHOP
FDA is announcing a virtual 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. 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
This meeting will be held in virtual format only. Registration is required for online attendance and will be available until 5:00 pm on August 2, 2020.
To register for this workshop, visit https://www.eventbrite.com/e/antifungal-drugs-to-address-unmet-medical-needs-public-workshop-tickets-95257211885
REQUEST FOR ORAL PRESENTATIONS
During online registration you may indicate if you wish to present during a public comment session, and which topic(s) you wish to address. We will do our best to accommodate requests to make public comments. 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.
ONLINE ATTENDANCE (WEBCAST)
This meeting will be available for online viewing, on the day of the meeting via the following link: https://collaboration.fda.gov/antifungaldrugs080420/
If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm.
To get a quick overview of the Connect Pro program, visit https://www.adobe.com/go/connectpro_overview.
EVENT POINT OF CONTACT
Antoinette Ziolkowski, at Antoinette.Ziolkowski@fda.hhs.gov. Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6221, Silver Spring, MD 20993-0002, 301-796-1300.