Adcon-L bioresorbable barrier gel regulatory update

After completing its review of GLIA's Application Integrity Policy (AIP) Corrective Action Plan, GLIA said the FDA will conduct an inspection of GLIA before deciding if the company will be removed from AIP. GLIA submitted the plan after the FDA suspended its review of two GLIA PMA supplements and one PMA (see BioCentury, Nov. 19, 2001). The AIP resolution process is necessary for GLIA to obtain a U.S. relaunch of Adcon-L. ...