Category Archives: Crisis Communications

FDA Presentation on Responses to 483s

    What?  What is a 483? A 483 is the vernacular for an FDA inspection of quality standards, manufacturing or the conduct of a clinical trial, and the discovery of deficiencies therein.  In other words, theygo through your manufacturing facility, for … Continue reading

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Transitioning to a New Communications Era

Much has been written about the reluctance of the pharmaceutical industry to become very involved in new media, both here and elsewhere.  But as communications in the Internet expands and unfolds, there are newer tools available and the way in … Continue reading

Posted in Crisis Communications, Current Affairs, Miscellaney, Useful Resources | 1 Comment

Most Recent Heparin Hearing

Here is some footage of the Heparin meeting from this week where it was stated that the contamination of Heparin would appear intentional.  Note: If you are a subscriber you will have to visit the Eye on FDA site to … Continue reading

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When it All Goes Bad – Crisis Communications During Tough Times

We all have a bad time of it some of the time.  Sometimes a confluence of events just throws us off our game.  It isn’t just one bad piece of news, it is one after another and your very character … Continue reading

Posted in Crisis Communications, Pharma Industry Image | 1 Comment

What is a Cholesterol Patient to Think?

I have very high cholesterol.  I don’t even want to tell you how high.  But I am also a bit of a statin-phobe.  So when my doctor prescribed Vytorin, despite the extremely attractive direct-to-consumer advertising, I resisted.  Vytorin is a … Continue reading

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