REGULATORY
Risk Management Plans for 8 APIs Published Since April 2013; Will Be Required for Approval of New Drugs and Biosimilars Starting October 1, 2014
More than a year has passed since the introduction of drug risk management plans (RMPs) in order to assess risks from the development phase through the post-marketing phase and help ensure drug safety. RMPs for a total of eight active…
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REGULATORY
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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…





