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News from CDER
 

May 5. FDA issues an Update about Suicidal Behavior and Ideation and Antiepileptic Drugs. Drug Information

May 4. FDA updates information on the 2009 H1N1 Flu Virus. H1N1 Flu

May 1. FDA approves pancrelipase (Creon Delayed-Release Capsules) for adult and pediatric patients with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF), chronic pancreatitis, and other conditions. Drug information

April 30. FDA updates the Early Communication about an Ongoing Safety Review of Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B). Information

April 29. FDA updates information on the 2009 H1N1 Flu Virus. Information

April 22. FDA updates action on Plan B (levonorgestrel) tablets. FDA Statement

April 14. FDA imposes restrictions on Coast IRB due to violations. FDA News

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Drug Safety: About FDA's New Drug Safety Initiative

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Featured Links

  A new FDA web site is coming soon
  Starting June 1, 2009, FDA will no longer accept paper submissions for Registration and Listing. For more information, visit the FDA Data Standards Council website or contact spl@fda.hhs.gov
  FDA's Office of Criminal Investigations (OCI)
  What You Should Know
about Prescription Drug Advertisements
  Facts@FDA Download available Structured Product Labeling



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Page Last Updated: May 4, 2009

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