Gliatech Adcon
This article was originally published in The Gray Sheet
Executive Summary
All regulatory submissions related to the anti-adhesion technology over the next two years must be reviewed and certified by an independent auditor prior to submission to FDA under an agreement resolving issues raised in a December 2000 application integrity policy (AIP) letter from the agency. Gliatech plans to auction its Adcon assets as part of bankruptcy proceedings; the device is not available in the U.S. (1"The Gray Sheet" Sept. 30, 2002, In Brief)...