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U.S. Department of Health and Human Services

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Drug Safety Oversight Board Meeting: December 6, 2007 Public Summary

  • The Board discussed Public Health Advisories, Healthcare Professional Information Sheets and Early Communications of Ongoing Safety Reviews posted since the July 12, 2007 meeting.
  • The Board reviewed the new legislative provisions in the FDA Amendments Act of 2007 (FDAAA) that pertain to operations of the DSB, and discussed whether the CDER Manual of Policies and Procedures for the DSB (4151.3) should be modified to incorporate the Board’s new FDAAA responsibilities. 
  • The Board heard presentations and discussed studies related to the performance of transdermal systems for delivering fentanyl.