- June 3, 2022
- 9:00 AM - 5:00 PM ET
This public workshop is currently being scheduled and planned as a virtual meeting. The Food and Drug Administration is announcing the following public virtual workshop entitled "Development Considerations of Antimicrobial Drugs for the Treatment of Uncomplicated Urinary Tract Infections (uUTI)." The purpose of this virtual public workshop is to discuss nonclinical and clinical considerations regarding developing antimicrobial drugs for the treatment of uncomplicated UTI.
ABOUT THE PUBLIC WORKSHOP:
The workshop will focus on nonclinical and clinical considerations regarding antimicrobial drug development for uncomplicated UTI. Discussions are planned around the following areas:
• Current state of clinical care for uUTI
• Nonclinical considerations and pathophysiology
• Microbiological and clinical pharmacology tools and approaches
• Trial design considerations, including the composite primary endpoint of clinical and microbiological success
ONLINE ATTENDANCE (WEBCAST):
This virtual public workshop will be webcast at: https://fda.zoomgov.com/j/1616027961?pwd=MlpvRHJmK0pjRWlEZzd4VUtoMGFyQT09
For more information about Zoom, please visit https://support.zoom.us/hc/en-us/articles/206175806-Frequently-asked-questions.
This meeting will be held in virtual format only. Registration is required for online attendance and will be available until 5pm on June 1, 2022. To register for this workshop, visit https://www.eventbrite.com/e/antimicrobial-drugs-for-the-treatment-of-uncomplicated-uti-tickets-252262141857
REQUEST FOR ORAL PRESENTATIONS
During online registration you may indicate if you wish to present during a public comment session or participate in a specific session, and which topic(s) you wish to address. We will do our best to accommodate requests to make public comments. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation, or submit requests for designated representatives to participate in the focused sessions. Following the close of registration, we will determine the amount of time allotted to each presenter (no more than 5 minutes) and the approximate time each oral presentation is to begin and will select and notify participants by May 27, 2022. All requests to make oral presentations must be received by the close of registration on May 20, 2022 must be emailed to Sunita Shukla (Sunita.Shukla@fda.hhs.gov) with the title and brief description of your topic. If selected for presentation, any presentation materials must be emailed to Sunita Shukla (Sunita.Shukla@fda.hhs.gov) no later than May 27, 2022. No commercial or promotional material will be permitted to be presented or distributed at the public workshop.
All meeting materials, including agenda, panelist affiliations/disclosures, speaker slides, workshop recording and transcript will be post here shortly before or after the completion of the workshop. Please check this site regularly for updates.
EVENT POINT OF CONTACT
Lori Benner and/or Antoinette Ziolkowski, 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