March 2012 Posts

Analysis of a Warning Letter

Mark Crawford

What a difference some wording makes!

On March 6, the U.S. Food and Drug Administration issued a warning letter to Breathable Foods Inc. for false or misleading statements regarding its product AeroShot. It was told this “caffeine inhaler” could pose risk to children and adolescents and in combination with alcohol. (more…)

Mobile Is the Name of the Game (But Can the FDA Keep Up?)

Mark Crawford

According to the PricewaterhouseCoopers and the mobile operator industry association GSMA report Touching Lives through Mobile Health: Assessment of the Global Market Opportunity, global mobile health revenues could reach US$23 billion by 2017, driven by rapid growth in Europe and Asia. Monitoring services, such as those for chronic disease management, will account for 65 percent of the market, followed by diagnostic services. (more…)

Breast Implant Fiasco in France Could Have U.S. Ramifications

Mark Crawford

On February 9 European Health and Consumer Policy Commissioner John Dalli called for immediate action from the EU to ensure stringent implementation of the current legislation on medical devices. This was in response to the fraudulent use of non-medical grade silicone in breast implants manufactured by the Poly Implant Prothèse (PIP) Company inFrance. The European Commission is now scrambling to tighten controls on the approval of medical devices and restore patient confidence. (more…)

The Newest Kind of Risk

Mark Crawford

It’s a high-tech world full of high-tech solutions that give us comfort and peace of mind. We’ve got risk and quality management practices in place that free us up to charge ahead with business—but do we look back enough over our shoulders, or do we fall victim to complacency—like, “Hey don’t sweat it, if it hasn’t happened yet it’s not going to happen.”   (more…)