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What's New by Category
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
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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)
- Establishment of Prescription Drug User Fee Rates for Fiscal Year 2009 [Text] [PDF] (Posted 7/31/2008)
- Warning Letters
Specific
Audiences
- Drug Safety Oversight Board Meeting,
July 17, 2008, Public Summary
- The Prescription Drug User Fee Act (PDUFA) News:
(8/20/2008)
- The FY 2009 Product and Establishment Fee Invoices were mailed Friday, August 15, 2008. Full payment of the invoice is due by October 1, 2008. If you do not receive your invoice by August 25, 2008, please contact Michael Jones or Beverly Friedman at 301-796-3602.
- Pediatric Drug Development:
- Certification to Accompany Drug, Biological Product, and Device Applications or Submissions (12/26/2007)
- Office of Generic Drugs:
- Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated 9/5/2008)
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Last updated: October 2, 2008
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