Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.
Spotting shifting trends in opioid addiction and using a systematic approach to monitoring them is essential to protecting the public from the opioid crisis and intervening against it, top FDA officials said in the New England Journal of Medicine. Read More
Drug and device advertising, marketing and promotion has come a long way from 30-second TV spots. These days the cutting edge is social media, product placement, engaging influencers, reality TV, pop-up shops and more. View
The opioid crisis is out of control and drugmakers are in the crosshairs. The President is tweeting, the FDA has launched an Opioid Task Force, lawsuits are sprouting in courthouses across the land, and even local governments (Chicago is one) are investigating. View
The FDA has upped its drug safety game since the last edition of Guide to FDA Drug Safety Regulation, adding more than 30 new, revised and finalized pharmacovigilance guidances, 12 of them in 2015-2017 alone. View
“Lean management” has come to the drug and device world, improving quality, ensuring compliance and boosting profits for those who adapt its ways to the production floor. If you’re not among them yet, then listen up. View
There’s a transformation going on in the clinical trials world. It’s called mobile health (“mHealth”), and it entails use of smartphones, sensors and wearables to monitor trial subjects in ways not previously possible. View
The 21st Century Take on Observational Studies walks you through everything you need to know about the opportunities and pitfalls observational studies can offer. The report looks at the growing trend toward observational research and how provisions in the 21st Century Cures Act create even more incentives to rely on real-world evidence in the development of medical products. View