COMMENTARY
Beyond Risk Management: RMPs Provide Opportunity for Post-Marketing Drug Development and Product Differentiation
The Ministry of Health, Labor and Welfare (MHLW) introduced on April 1 a new system that will require drug makers to submit pharmaceutical risk management plans (RMPs) when they file applications for the approval of new drugs and biosimilars. Since…
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COMMENTARY
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We had just gotten off a call with a client in Europe, and we’d received a bit of an earful. “Philip,” the client pressed, “what can this candidate bring to us? We know what he does, but what has he…





