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Mod3_pt5_CDER_Communication_2.pdf;JSESSIONIDVISTA=CLWsT6kpFhW24ShkvptZLj4TPtbyWZQtB6vTpf5dqJh11QmC6h

Mod3_pt5_CDER_Communication_2.pdf;JSESSIONIDVISTA=CLWsT6kpFhW24ShkvptZLj4TPtbyWZQtB6vTpf5dqJh11QmC6h

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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 Main FDA Address & Phone Number US Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Phone: (888) 463-6332 CDER Drug Information Line Website: www.FDA.gov/Drugs
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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 The 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: www.FDA.gov/Drugs
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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. FDA’s Office of Orphan Products Development (OOPD) (800) 300-7469 Other Activities – Orphan Drugs 8 Orphan Drug Act Orphan Drug Act states: Sponsors are granted seven years of marketing exclusivity after approval of its orphan drug product.
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