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.