• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Training and Continuing Education

  • Print
  • Share
  • E-mail

Section Contents Menu

Guidance Webinars

?
-

Resources for You

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On Friday, September 27th, 2013, FDA presented a webinar on new Draft Guidance for Industry Antibacterial Therapies for Patients With Unmet Medical Need for the Treatment of Serious Bacterial Diseases.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 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/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