dijous, 6 de març del 2014

Valor Medical and execs plead guilty to concealing device toxicity from FDA




Valor Medical and 4 of its top brass admit to concealing required data from FDA regulators while undergoing review for an aneurysm treatment implant.





Valor Medical and execs admit concealing device toxicity from FDA

California biotech company Valor Medical, 4 executives and a consultant admitted to the Dept. of Justice that they concealed information about their Neucrylate diagnostic assay, hiding toxicity reports that were required as the product was undergoing FDA premarket review.


Dept. of Justice (DOJ), Food & Drug Administration (FDA), Valor Medical

Legal News, News Well, Clinical Trials, Investigational Device Exemption (IDE), Patient Safety, Food & Drug Administration (FDA)

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