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Nutrition Companies Are Regulated For Product Safety Too

The pharmaceutical and medical device industries continue to be under close scrutiny by the FDA when it comes to product safety and the reporting of adverse events. With stringent regulatory requirements that’ll make any company or patient cringe, there’s no way to hide from authorities. And, rightly so. But, guess what? There are also adverse […]

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4 Ways To Submit A MedWatch 7-Day Report

Over the years we have seen some general confusion regarding the use of the FDA MedWatch 7-day report for fatal blood collection or transfusion reporting versus the standard 7-day alert requirement for FDA individual case safety reports from IND trials. Some of the safety systems that our company has worked with over the years do […]

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Canada’s New “Vanessa’s Law” Contains New Adverse Event Reporting Requirements

On November 6, 2014, Canada passed Vanessa’s Law, a new piece of legislation designed to protect patients from unsafe drugs and medical devices. The law comes after many complaints from citizens that the country wasn’t doing enough to oversee the safety of products sold in the marketplace or the clinical trials being conducted in the […]

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Direct From The Pharmaceutical CEO To You The Consumer

What do our pharmaceutical product advertisements indicate about our national ideals, given the myriad of advertisements seen on the Internet, TV, in magazines, or heard on the radio here in the United States? Interestingly, the United States and New Zealand are the only developed nations that allow direct -to-consumer (DTC) advertising (Liang & Mackey, 2011). […]

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Big Data, Big Data, What Can You Help Hospitals See?

While big data is a catchy buzzword and many race to offer their own definition of it, many still struggle to understand what it really means and question its real value. According to a recent survey conducted by Talend, only 10% of respondents were engaged in a large scale big data implementation project, while 36% […]

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