Mod3_pt5_CDER_Communication_2.pdf;JSESSIONIDVISTA=CLWsT6kpFhW24ShkvptZLj4TPtbyWZQtB6vTpf5dqJh11QmC6h

Mod3_pt5_CDER_Commun - Communicating with CDER Resource FDAs Center for Drug Evaluation and Research www.FDA.gov/Drugs FDA Contact Information Main

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1 Communicating with CDER Resource: FDA’s Center for Drug Evaluation and Research www.FDA.gov/Drugs 2 FDA Contact Information US Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Phone: (888) 463-6332 •C D E
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2 3 CDER Communication • Division of Drug Information (DDI) For industry, healthcare, government professionals and consumers Request information on specific drugs, guidance documents, publications Email: [email protected] 4 Regulatory Communication • FDA.gov - Revised website (05/2009) improvements to make FDA.gov easier and more satisfying to use, creating new features that will allow industry, healthcare professionals and consumers to find information more quickly • Monitor FDA.gov website for changes
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3 5 FDA Office of the Ombudsman •T h e Office of the Ombudsman is the agency's focal point for addressing complaints and assisting in resolving disputes between companies or individuals and FDA offices concerning application of FDA policy and procedures. It serves as a neutral resource for members of FDA-regulated industries when they experience problems with the regulatory process that have not been resolved at the center or district level CDER Ombudsman Phone: (301) 796-3436 E-mail: [email protected] Other Activities within CDER Resource:
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4 7 Orphan Drugs – refers to drugs used to treat patients with rare diseases or disorders effecting <200,000 people in the U.S. • In the 25 years since the Orphan Drug Act was established, more than 300 orphan drugs have been approved.
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This note was uploaded on 01/01/2012 for the course PHAR 6010 taught by Professor Mullis during the Spring '11 term at University of Georgia Athens.

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Mod3_pt5_CDER_Commun - Communicating with CDER Resource FDAs Center for Drug Evaluation and Research www.FDA.gov/Drugs FDA Contact Information Main

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