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Guidance Webinar Online-Access Instructions:
To access this webinar on July 25, 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.
Access link: https://collaboration.fda.gov/guidancewebinars/
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On July 25, 2013, at 1:30PM (ET), FDA will present a webinar on a new draft guidance entitled "Draft Guidance for Industry on Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment"
This webinar,intended to encourage the submission of questions or comments while the guidance is still in draft form, will provide an opportunity to learn about the guidance from individuals involved in its preparation.
Questions may be submitted online during the webinar and will be addressed as time permits. All comments should also be submitted to docket so that they can be formally processed by FDA.
DRAFT Guidance
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM355128.pdf
Federal Register Notice
http://www.gpo.gov/fdsys/pkg/FR-2013-06-05/pdf/2013-13288.pdf
The Comment Period Will Close on 08/09/2013.
Please plan to join. Your comments are important.
Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration
Kimberly Struble
Division of Antiviral Products
Food and Drug Administration
Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration
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