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On July 25, 2013, at 1:30PM (ET), FDA will present a webinar on a new draft guidance entitled "Draft Guidance for Industry on Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment."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. The Comment Period Will Close on 08/09/2013.

DRAFT Guidance

Federal Register Notice

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 This e-mail address is being protected from spambots. You need JavaScript enabled to view it 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/

 

JUN-25-13 In response to the decision by the U.S. Preventive Services Task Force (USPSTF) to expand coverage requirements for the one-time testing of all baby boomers (born from 1945-1965) for the hepatitis C virus (HCV), Veronica Miller, PhD, Executive Director of the Forum for Collaborative HIV Research, issued this statement on behalf of the leaders in HIV/AIDS and viral hepatitis from government, academia, industry and the patient advocacy community that comprise the organization.

MAY-22-13 IDSA is asking for you to join them and lend your name to a letter in support of PEPFAR funding for the next fiscal year. Click here to read the letter and sign by Monday, June 3-Noon Eastern time.

MAY-20-13 Dr. Ronald Valdiserri writes to recognize the second anniversary of Combating the Silent Epidemic of Viral Hepatitis: Action Plan for the Prevention, Care & Treatment of Viral Hepatitis and to share an important announcement from Dr. Howard Koh about plans to update and renew the existing plan through 2014-2016.

Read more >>

MAY-06-13 Arthur Reingold, MD, professor of epidemiology and associate dean for research at the UC Berkeley School of Public Health, was appointed to the Advisory Committee on Immunization Practices (ACIP) by Secretary Kathleen Sebelius of the Department of Health and Human Services. Learn more>>>

APR-15-13 TAG has released the report of their December 11-12, 2012, meeting of HIV advocates, service providers, and researchers from across the United States (U.S.) to review the current state of the national HIV response and discuss how to revitalize the National HIV/AIDS Strategy (NHAS). Read the report >>

APR-05-13 IDSA has released a fact sheet on the global impact and progress in fighting HIV-TB co-infection. Click here to see the fact sheet.

DEC-18-12  Outdated terminology has made it difficult to assess the clinical benefits of next-generation direct-acting antiviral drugs and combination therapies now in the pipeline. A new paper from the Forum for Collaborative HIV Research recommends the adoption of a standardized nomenclature that will bring simplicity and clarity to the field, allow for inter-trial comparisons and can be adapted to continuing advances in hepatitis C virus (HCV) drug development.