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.
DSOB Meeting Summaries
Date created: June 27,
2006 |