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DOJ as Your Ally: Government Weighs In on Patient Support Services Kickback Claims

On December 17, the U.S. Department of Justice, in an unprecedented application of its statutory authority under section 3730(c)(2)(A) of the False Claims Act, moved to dismiss 11 qui tam complaints pending in district courts...more

Beyond the Label: FDA Addresses Permissible Scope of Communications With Payors and Physicians

The draft guidances create a grey area between “on-label” and “off-label” communications that will require careful navigation as manufacturers develop HCEI analyses and promotional communications....more

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