FDA Small Business REdI Conference Fall 2013 – Registration now OPEN

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

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The Food and Drug Administration (FDA)
Small Business Regulatory Education for Industry (REdI)   

What: Fall REdI Conference
When: September 25-26, 2013
Where: The Hyatt Regency Bethesda
One Bethesda Metro Center (7400 Wisconsin Ave)
Bethesda, MD 20814

Registration is now open.

Please find updated details and registration information on our Conference webpage

The Regulatory Education for Industry (REdI) Conference is an FDA-led forum that brings together the regulatory educators from FDA’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH). The goal of this conference is to provide direct, relevant, and helpful information on the key aspects of drug and device regulations. Our intended audience is the small manufacturers of drug and/or device medical products who want to learn about how FDA approaches the regulation of drugs and devices.

Because the regulatory principles of drugs and devices are both similar and different, the REdI Conference features a cross-cutting plenary addressing FDASIA updates as they impact both drugs and devices, as well as individual break-out sessions which focus on the unique issues of drugs and devices. Common themes include:

• Meetings with FDA
• Clinical Studies and Review
• Site Inspections

This event is FREE!

For more information on CDER Small Business Assistance
workshops and webinars visit
www.fda.gov/smallbusinessdrugs 

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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