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The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
On Friday, September 27 from 1:00 PM - 2:00 PM (EDT), FDA will present a webinar on new Draft Guidance for Industry Antibacterial Therapies for Patients with Unmet Medical Need for the Treatment of Serious Bacterial Diseases.
The purpose of this draft guidance for industry (GFI) is to assist sponsors in the development of new antibacterial drugs to treat serious bacterial diseases, particularly in areas of unmet need, and new antibacterial drugs that are pathogen-focused (i.e., drugs that have a narrow spectrum of activity or are only active against a single genus or species of bacteria).
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 the docket so that they can be formally processed by FDA.
DRAFT GFI: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM359184.pdf
FR PUBLICATION DATE: 07/02/2013
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
For questions concerning the webinar, please contact Marsha Holloman (301-796-0731).
Webinar information on FDA’s Web site: http://www.fda.gov/Training/GuidanceWebinars/ucm369019.htm
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
This is an automated message delivery system. Replying to this message will not reach DDI staff. If you have comments or questions, please contact us at: 1-888-INFO FDA (1-888-463-6332) or (301) 796-3400 from 8:00 am - 4:30 pm Monday - Friday. You can also email us at druginfo@fda.hhs.gov.
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