Healthcare survey finds abundance of medical device security overconfidence

overconfident-shadow

When facing a determined adversary, it’s one thing to be confident, it’s quite another to be overconfident. But that’s what a new survey of healthcare IT professionals and biomedical engineers found: an overabundance of confidence when it comes to connected medical device security. According to the 2018 Zingbox Second Annual Connected Medical Device Survey, respondents believe […]

From Branded to Generic – Staying on Top of Labeling Changes

For companies with marketed medicinal products, it would be difficult to imagine a time when labeling changes or updates wouldn’t be occurring. Since labeling requirements extend to any and all written, printed or graphic material associated with a product, this necessitates a seemingly endless review cycle to ensure that appropriate changes are implemented whenever there […]

FDA Demand Continues the Evolution to Supply Chain Transparency and Visibility

How quickly would you be able to respond to notification of an illegitimate product in your supply chain? Or perhaps more to the point, just how good is your visibility into your supply chain? By Rick Ruiz, Partner, Life Sciences, DXC The US Food and Drug Administration has continued its push toward requiring greater visibility […]

Why Faster Adoption of Electronic Submissions for Promotional Materials Makes Sense

Change is the one constant, but let’s face it nobody likes it. From our experience in life sciences most companies tend to respond to new regulations and guidelines by putting off the inevitable. That’s certainly been the case with the FDA’s eCTD Module 1 guidance for advertising and promotional materials. While reticence to move to […]