By at least 2004, qui tam relators were filing False Claims Act (FCA) cases alleging that violations of current good manufacturing practices (cGMP) by companies selling federally reimbursed products led to false reimbursement claims
Does the Trickle of cGMP Prosecutions Foreshadow a Flood?
Significant uncertainty remains, but apparently, under particular circumstances, cGMP allegations will now be a top prosecution priority.
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