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SyntheMed receives FDA caution over trial

This article was originally published in Clinica

Executive Summary

Manufacturer of bioresorbable polymer implants SyntheMed has received a warning from the US FDA for alleged violations in its clinical trials process. The Iselin, New Jersey-based company is currently under FDA scrutiny after an inspection conducted at the firm in October 2007 raised concerns over the firm's failure to carry out certain record-keeping procedures for the clinical trial of its Repel-CV bioresorbable adhesion barrier film.

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