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Valor Medical hid critical information from FDA
Biomed's boardmember and clinical manager get a year of probation
H. Clark Adams
Cathy Bacquet
Local biomedical device maker Valor Medical and four employees admitted yesterday (January 30) that they did not provide the Food and Drug Administration (FDA) with required information that would have cast doubt on Neucrylate, a product the company was developing to treat aneurysms.
According to documents introduced in court, two preliminary tests contained unfavorable information. Upon hearing of unfavorable news, boardmember H. Clark Adams (later chief executive) sent an email to certain officials in the company stating, "Let's huddle and determine how we can overcome this obstacle."
The unfavorable results were not sent to the FDA, which, fortuitously, turned down the application despite not having the failed results. Adams and clinical manager Cathy Bacquet were given one year of probation. The fate of two other officials will be decided later.
Here's something you might be interested in.
Valor Medical hid critical information from FDA
Biomed's boardmember and clinical manager get a year of probation
Valor Medical hid critical information from FDA
Biomed's boardmember and clinical manager get a year of probation
H. Clark Adams
Cathy Bacquet
Local biomedical device maker Valor Medical and four employees admitted yesterday (January 30) that they did not provide the Food and Drug Administration (FDA) with required information that would have cast doubt on Neucrylate, a product the company was developing to treat aneurysms.
According to documents introduced in court, two preliminary tests contained unfavorable information. Upon hearing of unfavorable news, boardmember H. Clark Adams (later chief executive) sent an email to certain officials in the company stating, "Let's huddle and determine how we can overcome this obstacle."
The unfavorable results were not sent to the FDA, which, fortuitously, turned down the application despite not having the failed results. Adams and clinical manager Cathy Bacquet were given one year of probation. The fate of two other officials will be decided later.
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