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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


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

Continue reading