Drug Safety Oversight Board Meeting: June 15, 2006 Public Summary

The Executive Director updated the Board on patient information (PI) and healthcare professional (HCP) 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 angiotensin-converting enzyme inhibitors and gadolinium-containing contrast agents. The Board also discussed other emerging safety issues and strategies being considered to manage and track identified safety issues in CDER.