Day: September 24, 2015

The US FDA has approved the second implantable medical device for the treatment of symptoms of Parkinson’s disease. The device, Brio Neurostimulation System, provides relief from essential tremor, shaking and difficulty in walking and maintaining balance, that severely affect the quality of life of patients with Parkinson’s. There are several significant regulatory observations that can be made … Read more

This week President Obama announced the appointment of Dr. Robert Califf at the new Commissioner of the FDA. This was no surprise; Dr. Califf had already been acting as the FDA Commissioner since his hiring by FDA earlier this year. Dr. Califf’s major achievement before coming to FDA was creation of Clinical Research Institute at Duke University, which along … Read more

Lots of times, we don’t know what right or wrong is, and lots of times we do. No one takes responsibility for anything anymore. We foster, we obfuscate, and we rationalize. “Everybody does it”, that’s what we say. So we come to occupy a moral safe house, where everyone’s to blame so no one’s guilty. … Read more

In one of the more severe sentences ever in history for food safety violations, the CEO of the peanut butter company accused of selling salmonella contaminate peanut butter products was given a 28 year sentence for this event. His partner in the company, who is also his brother, was sentenced to 20 years while their quality assurance … Read more