Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

About FDA

  • Print
  • Share
  • E-mail
-

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 (all available at: Index to Drug-Specific Information) 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.

 

-
-