The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business
The Information Source for Regulated Domestic and International Small Pharmaceutical Business
The Food and Drug Administration (FDA)
Small Business Regulatory Education for Industry (REdI)
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
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
• 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
workshops and webinars visit
www.fda.gov/smallbusinessdrugs
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
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