by Melody Davis | Jul 12, 2018 | Management, Medical Affairs, Operations
The FDA issued new draft guidance last Friday along with a press release. Did you notice it?
No, not the one about biosimilars or off-label HEOR discussions. This guidance has the following title: ‘Indications and Usage Section of Labeling for Human Prescription Drug and biological Products – Content and Format.’ [1]
It is a mouthful, right?
The intent is to provide more concise and explicit descriptions of the conditions and populations for a specific drug indication. I had visions of infographic style labeling with clear and large icons to make scanning the document more accessible for clinicians (and the occasional patient that reads them). Nope. That is not where this is going.
by Jessica McLin | Jun 15, 2018 | Management, Medical Affairs, Operations, Training
First, the good news: Learning Management Systems (LMS) are improving exponentially to keep pace with increasing demand. It’s no surprise that, in the training industry, technology use overall was up in 2017, compared to the prior year. But did you know that the most commonly used technology was – you guessed it! – learning management systems? LMS use increased from 74% in 2016 to 86% percent in 2017. That’s an increase of 12%! Now for the bad news: with improved quality and functionality come more features (which is NOT the bad news part). The bad news is that means you have to learn about and understand all those new features and the acronyms, lingo, and intimidating terminology that come with them.