FDA Webinar: Webinar Draft GFI on Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment; Availability - July 25, 2013

On July 25, 2013, FDA presented a webinar on a new draft guidance entitled "Draft Guidance for Industry on Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment; Availability."

 

The webinar provided an opportunity to learn about the guidance from individuals involved in its preparation. It was also intended to encourage the submission of questions or comments while the guidance is still in draft form.

 

Questions may be submitted to docket so that they can be formally processed by FDA.

 

DRAFT GFI:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM355128.pdf

 

FR NOTICE

http://www.gpo.gov/fdsys/pkg/FR-2013-06-05/pdf/2013-13288.pdf  

 

Date FR NOA: 06/05/2013

Comment Period Closes: 08/09/2013

 

CONTACT:

Jeffrey Murray, MD, MPH

Deputy Director

Division of Antiviral Products

Office of Antimicrobial Products

Center for Drug Evaluation and Research (CDER)

WO, Bldg 22, Room 6370

301-796-1500

jeffrey.murray@fda.hhs.gov

Presentation Information

• Developing Antiretroviral Drugs for Treatment Webinar

Resources

• Archive of Past Webinars: http://www.fda.gov/Training/GuidanceWebinars/default.htm   

 

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