Supporting HIV care through education and innovation

FDA Presents: Draft Guidance on Vaginal Microbicides for the Prevention of HIV Infection

FDA Presents: Draft Guidance on Vaginal Microbicides for the Prevention of HIV Infection

Event Date: Tuesday, January 22, 2013 - 2:00pm to 3:30pm

Event Type: Webinar/Online Event

Description

This webinar will focus on select sections of the guidance including: 

  • Clinical considerations in early phase development
  • Key safety considerations including safety data in specific populations such as pregnant women and adolescents,
  • Phase 3 trial design issues,and
  • Risk-benefit considerations.

Other topics that will be covered in brief include non-clinical development considerations and approaches to combination product development. The webinar is intended to provide developers, industry, and academia an overview of key issues discussed in this draft FDA guidance.

Webinar Time: ET