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This page lists new and revised documents posted to the CDER web site. Each listing will remain on this page approximately 30 days. The dates listed indicate the dates of posting to the CDER web site, not the dates of origination or revision. When viewing a document, click your browser's "refresh" or "reload" button to make sure you are seeing the latest version. 

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 In the News

  • FDA has been made aware of preliminary safety findings from a clinical trial conducted in Germany investigating the use of epoetin alfa to treat acute ischemic stroke. MedWatch Safety Information(9/26/2008)
  • Covidien and Mallinckrodt Inc. inform healthcare professionals of important new safety information in prescribing Phosphocol P 32. MedWatch Safety Information (9/18/2008)
  • FDA Issues Warning Letters to Ranbaxy Laboratories Ltd., and an Import Alert for Drugs from Two Ranbaxy Plants in India. Drug Information. (9/16/2008)

Drug Information

Regulatory Guidance

  • Establishment of Prescription Drug User Fee Rates for Fiscal Year 2009 [Text] [PDF] (Posted 7/31/2008)
  • Warning Letters

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Last updated: October 2, 2008

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