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U.S. Department of Health and Human Services

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Drug Safety Oversight Board Meeting: March 20, 2008 Public Summary

  • The acting Executive Director updated the Board on recent communications including Healthcare Professional Sheets and Public Health Advisories (PHAs) posted since the last meeting regarding the drugs:
    • Tiotropium bromide (marketed as Spiriva) and Formoterol fumarate (marketed as Foradil)
    • Hydrocodone (marketed as Tussionex Pennkinetic Extended Release Suspension)
The safety related communications listed above were announced through MedWatch, CDER’s audio Podcasts and under News from CDER on CDER's home page.
  • The Board discussed the development of a pilot program for sharing and exchanging safety communications with other government healthcare organizations. 
  • The Board heard an update on the status of heparin. 
  • Finally, the Board reviewed data from and discussed issues on communicating information about a recently completed chemoprevention trial.