The Orbit Blog

Controlled & Restricted Distribution
Mary Coleman

RMP and REMS: The Most Stringent Risk Minimization Measures – Restricted Distribution

Background The past two decades have seen a fundamental “swing of the pendulum” where regulatory agencies have increasingly scrutinized the patient safety risks associated with medications. This has led to a rising number of Risk Minimization commitments regulators are requiring from pharma and biotech companies. To handle tasks of tracking and managing Risk Management activities

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