Medical Science Liaison Institute

Off-Label, Safe Harbors, and MSL Compliance

“Dissemination of Off-Label Information, Safe Harbors, and Conduct of Medical Science Liaisons.” Reprint series from MSL Quarterly 2004 on MSL Compliance.

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Off-Label, Safe Harbors, and MSL Compliance

DISSEMINATION OF OFF-LABEL INFORMATION, SAFE HARBORS, AND CONDUCT OF MEDICAL SCIENCE LIAISONS 3


Introduction 3


Quest for “Safe Harbor” 3


The FDAMA Effect 4


Where “Safe Harbor” is Not 4


What Effective Compliance Really Requires 6


References 7

8.25×10.75″ 8 pages.

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