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Drug Safety Oversight Board Meeting
October 16, 2008, Public Summary

  • The Executive Director updated the Board on Public Health Advisories (PHAs) and Information for Healthcare Professionals (HCP) sheets posted since the September 18, 2008, meeting (available at http://www.fda.gov/cder/drug/DrugSafety/DrugIndex.htm) and those currently in development.


  • The Board discussed recent data from an investigational study of an erythropoiesis stimulating agents (ESA) when used as a neuroprotectant in the treatment of acute ischemic stroke patients.


  • The Board had a general discussion with a representative from a leading medical journal about the journal’s prepublication policy as it relates to safety information.


  • The Board was updated on the progress of the pilot project with a federal health organization in which risk communications are shared prior to public release. There was discussion about broadening this project to other federal health systems.

 

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Date created: October 30, 2008

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