HIV/AIDS Update - Webinar “ Draft Guidance Vaginal Microbicides: Development for the Prevention of HIV Infection"

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: HIV/AIDS Update - Webinar: “ Draft Guidance Vaginal Microbicides: Development for the Prevention of HIV Infection"

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On Tuesday, January 22, 2013, from 2:00 - 3:00PM (ET), FDA will present a webinar to discuss the recently published draft guidance for industry entitled, “FDA Guidance for Industry Webinar on Draft Guidance Vaginal Microbicides: Development for the Prevention of HIV Infection"

 

Presenters:

• Charu Mullick, M.D.
• Kimberly Struble, Pharm.D.
  

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.

Instructions for online access to the webinar :

To access this webinar, follow the link provided below. Audio will broadcast from your computer speakers.

After following the link, enter as a guest and provide your FULL NAME and organization (i.e. "John Smith - FDA/CBER"). The host will then allow you to enter. If you experience technical difficulties email Jeffery.Rexrode@xxxxxxxxxxx for assistance.

Closed captioning will be provided.

 

Questions/Comments can be submitted live via a Q/A chat window during the webinar.

 

Webinar Access link: https://collaboration.fda.gov/guidancewebinars/

Background:

Federal Register Notice

 

Draft Guidance For Industry on Vaginal Microbicides: Development for the Prevention of HIV Infection

If you have never attended a Connect Pro meeting before, please test your connection before the lecture by following this link: https://collaboration.fda.gov/common/help/en/support/meeting_test.htm

Richard Klein
Office of Special Health Issues
Food and Drug Administration

 

Kimberly Struble
Division of Antiviral Products
Food and Drug Administration

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