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  #1  
Old December 22nd, 2012
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Minuteman Minuteman is offline
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Default FDA seeking comments on Draft Guidance for Industry on Vaginal Microbicides (Deadline 21 Feb 2013)

http://www.regulations.gov/#!documen...12-D-1120-0002

Excerpt from guidance document:

Quote:
Sexual transmission accounts for the majority of HIV infections both in the United States and globally. Behavior change through counseling, male and female condoms, antiretroviral therapy for the infected partner, voluntary male medical circumcision, and treatment of STIs can reduce the risk of HIV acquisition. However, despite these prevention methods, HIV incidence in the United States has not declined and remains stable at 56,300 new infections annually (Hall, Song, et al. 2008). Worldwide, the annual incidence is estimated to be about 2.7 million infections (UNAIDS 2011).
There is a 2000 character limit in the comment web form, but you can upload larger documents.

You may want to center comments around the notion that vaginal microbicides are intended to be a "female controlled" anti-HIV measure, but that male circumcision (purportedly) makes it more difficult to insist on condom use or refuse sex, and that some analyses suggest a higher rate of male-female HIV transmission when men are circumcised.

Researching and drafting comments with a view to the relatively straight forwarded matter of having token reference to male circumcision removed from this document would be a good opportunity for readers from the U.S. to start becoming familiar with the formal processes through which regulations are developed (see this post).

Please remember that your comments will be read by decision-makers in the FDA and to be firm but respectful (and ideally, provide links to scientific articles and other credible references) if you want to be taken seriously.
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  #2  
Old December 22nd, 2012
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Default Re: FDA seeking comments on Draft Guidance for Industry on Vaginal Microbicides (deadline 21 Feb 20

Quote:
Originally Posted by Minuteman View Post
http://www.regulations.gov/#!documen...12-D-1120-0002

Excerpt from guidance document:



There is a 2000 character limit in the comment web form, but you can upload larger documents.

You may want to center comments around the notion that vaginal microbicides are intended to be a "female controlled" anti-HIV measure, but that male circumcision (purportedly) makes it more difficult to insist on condom use or refuse sex, and that some analyses suggest a higher rate of male-female HIV transmission when men are circumcised.

Researching and drafting comments with a view to the relatively straight forwarded matter of having token reference to male circumcision removed from this document would be a good opportunity for readers from the U.S. to start becoming familiar with the formal processes through which regulations are developed (see this post).

Please remember that your comments will be read by decision-makers in the FDA and to be firm but respectful (and ideally, provide links to scientific articles and other credible references) if you want to be taken seriously.
It is very irresponsible to include mention of male circumcision in this policy. In the ONLY controlled trial to address the question of male-to-female HIV transmission, Wawer and Gray (Uganda 2009) observed that the Ugandan men they circumcised infected their female partners 50% more often than the men they left intact did. This finding has not been refuted by any other study.

Male circumcision does NOT reduce male-to-female HIV transmission.
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  #3  
Old January 17th, 2013
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Default Re: FDA seeking comments on Draft Guidance for Industry on Vaginal Microbicides (deadline 21 Feb 20

Webinar Draft Guidance Vaginal Microbicides: Development for the Prevention of HIV Infection" - ‏Tuesday, January 22, 2013, from 2:00 - 3:00PM (ET)

This just arrived as part of an FDA mailing-list subscription:

Quote:
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@fda.hhs.gov 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...eting_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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  #4  
Old February 14th, 2013
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Default Re: FDA seeking comments on Draft Guidance for Industry on Vaginal Microbicides (Deadline 21 Feb 20

Final week for lodging comments.
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