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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)....

Introducing Rebel Compliance Law, PC!
We are excited to announce the launch of Rebel Compliance Law, PC! Our focus remains the same Life Sciences compliance support we have been providing with SD Consulting Services, Inc., dba Rebel Compliance, expanding to now include legal offerings such as external...