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CCO Certifications and DOJ Fraud Section Updates
Summary On June 22, 2022, Lauren Kootman, the Assistant Chief of the DOJ’s Fraud Section’s Corporate Enforcement, Compliance & Policy Unit (CECP), reiterated the inclusion of Chief Compliance Officer Certifications stating that they “are going to be incorporated...
OPDP Untitled Letter – Althera Pharmaceuticals (06/02/2022)
Summary: On June 2, 2022, the FDA's Office of Prescription Drug Promotion (OPDP) issued an Untitled Letter to Althera Pharmaceuticals, Inc., for an HCP-facing promotional material about their LDL-C reducing combination statin drug, ROSZET (rosuvastatin and ezetimibe)....