REGULATORY
PMDA to Set Up New Consultation Services for RWD Use in Regulatory Submissions
The Pharmaceuticals and Medical Devices Agency (PMDA) will start offering new consultation services next month for the use of registry data in new drug applications (NDAs) and reexamination applications for drugs and regenerative medicine products. The move comes as part…
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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.…





