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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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• Consumer Education Helping you make informed decisions about using medicines.
• FDA Drug Safety Podcasts
• FDA Drug Safety Newsletter
 

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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