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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A few weeks ago, I had coffee with a very talented executive. Let’s call him Kenji. He has a great job, a big salary, and a solid team. But he was unhappy. He felt bored and wanted a new challenge.…





