Posts Tagged ‘FDA’

The electronic (or manual through the Safety Reporting Portal) reporting of post-marketed individual case safety reports (ICSRs) to the FDA will be required by mid-2015 (FDA, 2014), and the most efficient way to perform such activities is through an industry-proven adverse event reporting system, such as Oracle’s Argus Safety. Since this is the safety and […]

Just kidding. You may have read the story on TMZ of a New York businessman making big bucks off the panic surrounding Ebola. Guess what? The FDA hit him where it hurts. His site is down. Stop trying to trick the public. Stop being sleazy. That’s the message the FDA is sending to pharmaceutical, medical […]

The life sciences industry is one of the most heavily regulated in the world, which can make it a frustrating space to do business. But, retracing the current mass of regulations back to their roots can be like the spoonful of sugar that makes the medicine go down…and might even make you feel kinda good […]

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 […]

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 […]

It’s no secret that validation can be a bear. All of that documentation and testing, the multiple phases with pesky transition gates, a million reviews and approvals…it can really slow down an IT project, which often leads to questions about why on Earth we bother with it. Well, it all traces back to rules and regulations […]

Digitally signing documents is easier than you might think. It’s also much faster than having to print, sign, and scan them. And, of course, there’s a significant cost-savings for companies that frequently mail and store hardcopy documents. A product like CoSign can be a great solution for companies, especially those in highly-regulated industries that require […]

Jody Trader, a pharmacovigilance and drug safety specialist at MMS Holdings, a CRO based in Michigan, recently published a blog post on whether or not Microsoft Excel was sufficient for capturing and reporting adverse events. Since validated safety databases, such as Oracle’s Argus Safety, are often costly, sponsors and CROs continue to use spreadsheets for […]

The healthcare IT field is rapidly developing and changing. Emerging technology and updated regulations put pressure on healthcare providers and health plans to stay ahead of the curve. Perficient creates a monthly list that explores some of the current topics and issues in health IT. This list examines the most talked about issues and technologies […]