“Mitigating MSL Compliance Risk and Off-Label Prosecutions.” Reprint series from MSL Quarterly 2007 on MSL Compliance. Based on an Industry Conference Report by Tanya Douglas-Holland MD.

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MITIGATING COMPLIANCE RISK AND OFF-LABEL PROMOTION PROSECUTIONS AND OIG SCRUTINY OF MEDICAL SCIENCE LIAISON ACTIVITIES 3



Introduction 3



Latest Developments in Off-Label Prosecution 3



Mitigating the Risk of Private Lawsuits for Off-Label Uses 4



Role of Office of Inspector General’s (OIG) in Monitoring Off-Label Activity and Promotion 6



Importance of Integrating Federal Trade Commission (FTC) Guidelines into a Corporate Compliance program 7



Dissemination of Off-Label Information within Frameworks of Current Case Laws, FDA Rules, and Company Policies 7



Definition of a Medical Science Liaison (MSL) Role and Evaluation of MSL Risk Tolerance Level 8



Conclusion 11

8.25×10.75″ 12 pages.

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