Category Archives: Latest

20Jun/14
Global-Transformation

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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14Apr/14
obctacle

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

19Mar/14
caliper_s_color_pencil

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

21Feb/14
silverman-photo-200px

FDA Official Addresses the Benefits of Manufacturing Quality for FDA and Industry

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

06Feb/14
terumo-interview-series-banner

What Keeps Terumo Executives Up at Night?

By Daniel R. Matlis

In this exclusive interview with Terumo Cardiovascular Group Executives, Mark Lincoln and Chris Zarecki address key issues and trends impacting the Medical Technology industry in particular as well as the broader Life-Sciences industry.

Find out which industry trends keep Terumo Executives up at night in this three part “Executive Vision” interview series addressing:

  • Managing price and cost pressures
  • Dealing with the Excise tax
  • Adding value beyond quality and compliance
  • Tapping Emerging Markets for growth
  • Managing Med-Tech globalization, outsourcing and offshoring
  • Complying with increasing global regulatory pressures
  • Preparing for FDA’s Risk-Based Approach

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