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December 2011

John Avellanet

Reading the FDA Tea Leaves                                                  

by John Avellanet
Management Director, Cerulean Associates, LLC

Publisher Henry Luce once wrote, "Business, more than any other occupation, is a continual dealing with the future; it is a continual calculation, an instinctive exercise in foresight." When business mixes with regulation, foresight will, and must, be influenced by the anticipation of regulatory action.

As the 21st century continues to drive itself forward, it is becoming clear that the US Food and Drug Administration (FDA) is striving to meet modern challenges. Of especial relevance to executives in industries regulated by the FDA is the immediate impact—for the foreseeable future—of the trends shaping agency action. These actions may include the issue of guidance documents, inspectional strategies and medicinal product approvals/disapprovals. When considering these potential actions, the business executive has a simple question: Will I, my firm, or our products get caught in the crossfires of change without being prepared?

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Stephen F. DeAngelis

End-to-End Supply Chain Visibility: It's no VUCA-tion for Supply Chain Professionals

by Stephen F. DeAngelis
Technology and Supply Chain Sector Entrepreneur, Enterra Solutions, LLC

In a survey conducted by ChainLink Research, pollsters "found that the vast majority of respondents (nearly 80 percent) do not manage risks beyond their immediate first-tier suppliers. Instead, they rely on their immediate suppliers to manage those risks." With so many well-respected supply chain analysts talking about the importance of developing end-to-end supply chain visibility, 80 percent seems like a big number of non-believers. Perhaps it is the phrase "managing risks" that causes that number to be so high. After all, having supply chain visibility is not exactly the same thing as managing risk. Regardless, I suspect that most supply chain analysts would tell respondents who fall into the 80 percent group that they are being short-sighted. Lora Cecere, for example, believes that companies need to develop "value networks that extend from the customer's customer to the supplier's supplier, and that [they need to] sense, shape and respond by listening, testing and learning with minimal latency."

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You may know that the volume of adverse reporting is on the rise. Did you also know that recalls have risen slower than adverse events but have matched industry growth? And that, in general, critical, life-sustaining devices are responsible for a growing share of adverse event reports, but not of recalls?
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