Time: Friday April 23, 9:00am – 5:00pm ET
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.
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.