CDER Small Business Update

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

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Join patient advocates, drug and device industry leaders, researchers, government partners and investors at this major conference to address together "Shaping the Future Now" for rare diseases and orphan products.  Sponsored by NORD and DIA, with major input from FDA and NIH, this event will include general and breakout sessions with three themes:  policy, research and regulation, and special challenges.

The 2nd annual U.S. Conference on Rare Diseases and Orphan Products will take place October 22-24 in Washington DC. Everyone is welcome, and the program should be of particular interest to:

•   Researchers from academia and drug and device companies
•  Patient organizations and those interested in creating one
•  Senior managers from drug and device companies interested in rare diseases
• Investors focused on the future of orphan product development
• Policy experts who are concerned about federal or state policies that affect patients with rare diseases
• Providers of services to the rare disease community, including insurance providers and healthcare professionals
• Government officials responsible for rare disease research and orphan product oversight

Register by October 1 for the Early Bird rate. For more information please visit: DIA Rare Diseases 2012

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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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