This article was originally published in The Gray Sheet
Corrective action plan submitted to FDA for the lumbar surgery anti-adhesion gel includes revised packaging for a raw material, as well as added manufacturing inspection and testing procedures. An ongoing, independent re-evaluation of clinical study MRI data also will be reviewed by FDA prior to a U.S. relaunch, the Cleveland firm says. Adcon-L was removed from the market in January 2001 due to concerns related to particulates in the raw material
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