Thursday, April 1, 2021

FDA Announces Virtual Public Workshop on Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea - Drug Information Update

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FDA Center for Drug Evaluation and Research Division of Drug Information

FDA Announces Virtual Public Workshop on Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea

The Food and Drug Administration, the National Institute of Allergy and Infectious Diseases (NIAID), and the Centers for Disease Control and Prevention (CDC) are announcing a virtual public workshop, Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea.The workshop is scheduled on April 23, 2021 from 9:00 am to 5:00 pm EST.   

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. 

Those interested in attending the virtual workshop should register early via Eventbrite. Registration is required for online attendance and will be available until available until 5:00 pm EST on April 21st, 2021. 

During online registration, please indicate if you wish to present during the virtual public comment session, and which topic(s) you wish to address. All requests to make oral presentations must be received by April 8th, 2021. 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 April 13th, 2021  

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