- October 27, 2020
9:00 AM - 5:00 PM ET
WORKSHOP POSTPONED: Thank you for your interest in this critical meeting. FDA, NIAID and CDC have decided to postpone this workshop until early 2021 due to the clearance time associated with critical documents that are needed to have more up to date discussions and informed decision making around gonorrhea drug development. We will continue to actively monitor the availability of these documents and update the date for holding the virtual workshop in 2021. Please check this webpage periodically for current information and re-register once the date is set.
Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea; Public Workshop
This public workshop is currently being scheduled and planned as a virtual meeting. The Food and Drug Administration, NIAID and CDC are announcing the following public virtual workshop entitled "Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea." The purpose of the public virtual workshop is to discuss the nonclinical and clinical pharmacology data and clinical trial design considerations regarding developing antimicrobial drugs for the treatment of gonorrhea.
ABOUT THE PUBLIC WORKSHOP
FDA, NIAID and CDC are announcing a public workshop regarding the development considerations of antimicrobial drugs for the treatment of gonorrhea. The workshop will focus on the current state and nonclinical and clinical trial design considerations regarding antimicrobial drug development for gonorrhea and include the following topic areas:
- Animal models
- Clinical pharmacology considerations
- Trial design considerations for gonorrhea, such as enrollment strategies, choice of comparators and site of infection.
This meeting will be held in virtual format only. Registration is required for online attendance and will be available until 5pm on October 26, 2020
To register for this workshop, visit https://www.eventbrite.com/e/antimicrobial-drugs-for-the-treatment-of-gonorrhea-public-workshop-tickets-105417771392
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. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations and request time for a joint presentation. 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 October 16, 2020. All requests to make oral presentations must be received by October 13, 2020. If selected for presentation, any presentation materials must be emailed to ONDPublicMTGSupport@fda.hhs.gov no later than October 20, 2020. No commercial or promotional material will be permitted to be presented or distributed at the public workshop.
A full agenda will be available before the workshop. All other meeting materials, including speaker slides and transcripts, will be available here before and after the workshop. Please visit this page for any updates.
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/workshop102720/
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
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.