martes, 9 de septiembre de 2014

FDA Webinar on Draft Guidance for Industry- Uncomplicated Gonorrhea: Developing Drugs for Treatment - September 11

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)

FDA Webinar on Draft Guidance for Industry-
Uncomplicated Gonorrhea: Developing Drugs for Treatment - September 11

On Thursday, September 11, 2014, from 10:00 a.m. – 11:00 a.m. EDT, FDA will present a webinar on the draft guidance for industry Uncomplicated Gonorrhea: Developing Drugs for Treatment.

The purpose of this draft guidance is to assist sponsors in the development of new antibacterial drugs for the treatment of uncomplicated gonorrhea. 

Date of FR Publication: 06/07/2014
Date Comment Period Closes: 09/17/2014
Agency/Docket Number: Docket No. FDA-2014-D-0609 

Webinar Speaker:

Joseph G. Toerner, M.D., M.P.H.
Deputy Director
Office of Antimicrobial Products
Center for Drug Evaluation and Research

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. Closed captioning will be provided.
Questions/Comments can be submitted live via a Q/A chat window.

Please note: There is a user capacity limit for this webinar. For those who cannot enter the webinar, please know that it will be recorded and a link will be posted to this page within one business day.

For questions concerning the webinar, please contact Marsha Holloman (301-796-0731). 

The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance and information to regulated domestic and international small pharmaceutical business and industry through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM - 4:30PM.
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