We’re at a moment of extraordinary opportunity to improve public health. New innovations are giving us fundamentally better ways to address disease. Some of the same technology is providing consumers with a broader selection of foods that can improve peoples’ diets and products that can expand their choices. At the same time, we also face a lot of new challenges. The steps FDA takes to advance these opportunities, and address uncertainties, will directly affect the lives of families.

True to my profession as an engineer, I am a total geek at heart and proud of it. Spending time in automobile museums always fascinates me. It excites me to see a prescient innovator from the past come up with an idea like headlights. The first ones were Limelight carbide models that had a nasty habit of setting the horseless carriage on fire. Within a couple of generations there were sealed beam electric headlights, safe, effective, and increasingly affordable.

The technologies driving artificial intelligence (AI) are expanding exponentially, leading many technology experts and futurists to predict that machines will soon be doing many of the jobs that humans do today. Some even predict humans could lose control over their future.

ISO 9001:2015 has significant structural changes that differentiate it from the previous standard. The new high-level structure is common to all ISO management system standards (i.e., quality, environmental,  IT security) and enables us to start looking at integration of these systems. There is a standard core text and structure and, important for ISO 9001, there is now the inclusion of services.

Our Sept. 8, 2017, episode of QDL examined a different way to conduct clinical trials, discussed fixing problems before they occur, and in the aftermath of Hurricane Harvey looked at resources for building a more resilient and sustainable infrastructure.

“A Better Way to Design Clinical Trials”

In the last week of August 2017, two extreme weather events occurred on opposite sides of the world. Hurricane Harvey brought record-breaking rain and catastrophic flooding to Houston, Texas, causing loss of life, mass evacuation of people, and damage estimated to be in billions of dollars. Around the same time, Mumbai, India, received extremely heavy monsoon rains, flooding roads, crippling the city’s public transport, and stranding thousands of people.

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A new report by Jupiter Research says $8 trillion will be the price tag—within the next five years—of cyber attacks against businesses around the world. Hacks and other forms of digital theft are accelerating despite what would seem to be nonstop efforts by corporations to harden their networks with anti-virus software, network intrusion filters, virtual private networks, vulnerability testing, and all manner of expensive gadgets to keep the bad guys out.