REGULATORY
Applications for Partial Modification to Suffice to Change Manufacturing Processes for Biopharmaceuticals: MHLW Notification
The Ministry of Health, Labor and Welfare (MHLW) issued a notification on July 5 that allows drug makers to change manufacturing processes for biopharmaceuticals by filing applications for the partial modification of existing approvals. Up to now, they have been…
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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.…





