Category Archives: Latest


Hovering Through the Human Heart

By Daniel R. Matlis

Last month, I had the opportunity to attend Dassault Systèmes’ analyst conference at the company’s headquarters in Vélizy, France, just outside Paris. There, I was briefed by company executives on Dassault’s Life Sciences strategy.

My most memorable experience at the conference was that of hovering through the human heart.  While Dassault scientists have not yet devised a way to miniaturize matter by shrinking individual atoms, like in Fantastic Voyage, they have achieved the next best thing. Continue reading


FDA Continues Global Transformation

By Ellyn McMullin

In June of 2011 I published an article “FDA Wants to Transform into a Global Agency” after the Food and Drug Administration unveiled a new global strategy to help ensure safety and quality of imported products.

Recently, Howard Sklamburg, FDA’s Deputy Commissioner for Global Regulatory Operations & Policy posted a blog entitled “Ensuring Pharmaceutical Quality Through International Engagement” to provide an update on the Agency’s pursuit of global participation.

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Is Compliance an Obstacle to Quality?

By: Daniel R Matlis

Can you distribute poor quality products while complying with regulatory requirements?  Sure, after all, you can conduct a recall of poor quality products in compliance with all applicable regulations.

Regulatory Compliance and Quality are NOT the same.  In fact, the industry’s hyper-focus on compliance is often an obstacle to quality.

This distinction seems to be the renewed focus at the FDA, from the Commissioner on down…  Continue reading


Show FDA Your Commitment to Quality

By Daniel R. Matlis

The “Case for Quality Initiative” is a strategic priority for the US Food and Drug Administration. To support this initiative, the agency is working to implement policies that go beyond compliance with regulations and provide an enhanced focus on the manufacturing quality.

To learn more about this strategic shift at FDA, I spoke with Steve Silverman, Director of the Office of Compliance at the FDA’s Center for Devices and Radiological Health.

We are publishing the interview in a series of articles covering our discussion on the Case for Quality Initiative. Continue reading