Genotox Laboratories agrees to pay $5.9M to resolve False Claims Act and Federal Anti-kickback Statute allegations that it paid commissions to third party marketing firms and independent contractor sales representatives to arrange for laboratory testing; The former CEO, COO, and quality assurance director of Magellan Diagnostics are indicted for allegedly concealing a serious malfunction in their blood lead testing system from the FDA and consumers; Brief discussion of corporate officer liability under the Park Doctrine; The FDA See more +

Genotox Laboratories agrees to pay $5.9M to resolve False Claims Act and Federal Anti-kickback Statute allegations that it paid commissions to third party marketing firms and independent contractor sales representatives to arrange for laboratory testing; The former CEO, COO, and quality assurance director of Magellan Diagnostics are indicted for allegedly concealing a serious malfunction in their blood lead testing system from the FDA and consumers; Brief discussion of corporate officer liability under the Park Doctrine; The FDA issues draft guidance seeking comments regarding predetermined change control plans (PCCP) to allow for the preapproval of planned modifications to device software functions via machine learning. See less -