FDA Webinar: 60-Day Draft GFI On Antibacterial Therapies For Patients With Unmet Medical Need For The Treatment Of Serious Bacterial Diseases – September 27, 2013

On Friday, September 27th, 2013, from 1:00PM – 2:00PM (EDT), FDA will present a webinar on new Draft Guidance for Industry Antibacterial Therapies for Patients With Unmet Medical Need for the Treatment of Serious Bacterial Diseases.

This webinar will provide an opportunity to learn about the guidance from individuals involved in its preparation. It is 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.

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DRAFT GFI:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM359184.pdf

 

FR PUBLICATION DATE: 07/02/2013

https://www.federalregister.gov/articles/2013/07/02/2013-15783/draft-guidance-for-industry-on-antibacterial-therapies-for-patients-with-unmet-medical-need-for-the

 

Docket No. FDA-2013-D-074 (access via www.regulations.gov)

 

60-Day Comment Period Closes: 09/30/2013

 

Presenter:

Joseph G. Toerner, MD, MPH

Associate Director for Medical Affairs

Office of Antimicrobial Products

Center for Drug Evaluation and Research

U.S. Food and Drug Administration

marsha.holloman@fda.hhs.gov

 

For questions concerning this webinar, please contact Marsha Holloman  marsha.holloman@fda.hhs.gov (301-796-0731)

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Guidance Webinar Online-Access Instructions:

 

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.

 

Access link: https://collaboration.fda.gov/guidancewebinars

 

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

 

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/help/en/support/meeting_test.htm