Exploring the Nature of Scrutiny Surrounding Off-Label Information

December 6, 2011 at 9:00am
2nd Annual Life Science Regulatory Off-Label Communications Conference
Sheraton Society Hill HotelOne Dock Street (2nd & Walnut Streets)
Philadelphia, PA 19106

In the past ten years, the pharmaceutical industry, and more recently the device industry, has received a great deal of scrutiny surrounding off-label promotion allegations. Recent cases are significant not only because of their high fines, but also due to the methods in which the government prosecutes the manufacturers. While many organizations have worked diligently to combat these compliance issues, new areas of government scrutiny continue to emerge. This seminar will cover the following topics:

• Enforcement waves of the past decade
• Defining recent areas of government investigation
• Clarifying grey areas of off-label promotion

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David Restaino