Drug Safety Oversight Board Meeting: April 6, 2006, Public Summary

The Executive Director updated the Board on patient information and healthcare professional sheets (described below as “sheets”) and Public Health Advisories (PHAs) posted since the last meeting, and the Board discussed several of the actions. The drugs for which sheets and/or PHAs were posted included gatifloxacin (Tequin) and diazepam rectal gel (Diastat AcuDial). The Board also discussed other emerging safety issues and strategies being considered to manage and track identified safety issues in CDER