HIV/AIDS Update - New page on the FDA.gov site - Development of Topical Microbicides

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

Title: HIV/AIDS Update - New page on the FDA.gov site - Development of Topical Microbicides

You are receiving this message as a subscriber to the FDA HIV/AIDS electronic list serve. The purpose of the list serve is to relay important information about HIV/AIDS-related products and issues, including product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings and alerts to proposed regulatory guidances for comment.

Please do not reply to this message.

Microbicides are topically applied products which may reduce the risk of HIV acquisition across vaginal or rectal mucosa. Vaginal microbicides are vaginal products which reduce HIV acquisition in women. This new FDA website brings together a variety of materials on a single page, intended to serve as a source of relevant regulatory information for investigators and industry.

The website provides access to the following important information for those involved or interested in microbicide development:

•       Select presentations at public meetings including

  •        Regulatory perspectives for microbicide development including nonclinical and clinical considerations, 

  •       Critical considerations for special populations in microbicide development;

•       Peer-reviewed publications authored by FDA staff;

•       Presentations and transcript from 2003 FDA Antiviral Drugs Advisory Committee meeting for microbicides;

•       Links to relevant CDER guidances including a draft guidance for co-development of two unmarketed investigational agents for use in combination;

•       Link to CDER guidance website which lists guidance documents for drug development;

•       Information about communicating with FDA during drug development including the pre-investigational new drug (pre-IND) application consultation program which allows early communication prior to opening an IND;     

The posted items including presentations, publications, and guidances that describe FDA thinking on the topic and are not product-specific recommendations. Sponsors are strongly encouraged to contact the FDA with questions specific to their product.

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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