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Drug Safety Oversight Board Meeting
April 17, 2008 Public Summary

  • The Executive Director updated the Board on Public Health Advisories (PHAs), Information for Healthcare Professionals (HCP) sheets, Early Communications about an Ongoing Safety Review (EC), and Communications about an Ongoing Safety Review posted since the March 20, 2008 meeting (all available at http://www.fda.gov/cder/drug/DrugSafety/DrugIndex.htm) and those in development.

  • The Board discussed additional data and analyses on a drug as a follow up to the Early Communication about an Ongoing Safety Review.

  • The Board discussed the impact and effect of issuing Early Communications About an Ongoing Safety Review and considered possible alternative options to provide the public with information about safety reviews in progress.

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Date created: May 13, 2008
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