CDER Small Business Update

The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business

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On August 5, 2013, from 10:00 AM - 11:00 AM (EDT), FDA will present a webinar on a new draft guidance entitled "Draft Guidance For Industry On Expedited Programs For Serious Conditions Drugs And Biologics."

The 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 (see Federal Register (FR) Notice) so that they can be formally processed by FDA.

 

Draft Guidance

 

FR NOTICE

 

Online-Access Instructions for Webinar: 

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

. After following the link, enter as a guest and provide your FULL NAME and organization (i.e. "John Smith - FDA/CDER"). The host will then allow you to enter.

. Audio will broadcast from your computer speakers.

. Closed captioning will be provided.

. Questions/Comments can be submitted live via a Q/A chat window.

. If you experience technical difficulties, email Jeffery.Rexrode@fda.hhs.gov for assistance.

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The Small Business Assistance (SBA) program in the Center for Drug Evaluation and Research (CDER) provides guidance and information to regulated domestic and international small pharmaceutical business 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 SBA staff.  If you have comments or questions, please contact us Monday through Friday 8:00AM – 4:30PM.

• Email: CDERSmallBusiness@fda.hhs.gov
• Phone: 1-866-405-5367
• Phone: (301) 796-6707
• Website: http://www.fda.gov/smallbusinessdrugs
• Widget: http://www.fda.gov/Drugs/ucm153379.htm

Please take our CDER Small Business survey: https://www.surveymonkey.com/s/cdersmallbusiness

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