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.