Monthly Archives: April 2010

Weekly Roundup – 4/30/10

 It has been one busy week, not only for me personally (cross country biz travel) but on the FDA side of things as well.  Makes no sense to do anything but get started. Dendreon's Provenge Finally Gets Approval – In … Continue reading

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Communications and Marketing Implications of a Change in FDA Policy for Medical Device AdComms

In June of 2008, January of 2009 and again in June 2009 the General Accounting Office issued reports on the FDA and its oversight of medical devices.  The June 2009 report echoed findings from the earlier January report, put forth a recommendation … Continue reading

Posted in Advisory Committee Prepapartion, FDA Policy | Comments Off

FDA Pioneers New Level of Transparency – An Interview with Dr. Joshua Sharfstein

No kidding.  I mean it. Transparency is one of those buzz words that doesn't really mean much to people, because it means so many things to so many people.  As a result, in some ways, the word has lost its … Continue reading

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Banning Access to Social Media in the Workplace – Make Sense?

 This week I was in Chicago where I spoke at a meeting of the Illinois Association of Healthcare Attorneys as part of a panel of lawyers about my favorite topic – social media and healthcare.  In attendance were many lawyers who … Continue reading

Posted in New and Social Media | 1 Comment

Advisory Committee Transparency Update – FDA and EMEA

In the United States, new medicines are considered for approval by various consultant committees that the FDA  uses to help assess an application for approval.  In the European Union, human medicines are considered for approval by the European Medicines Agency … Continue reading

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