REGULATORY
RWD Use in Regulatory Submissions Could Start with Rare Diseases: PMDA Chief
The envisaged use of real-world data (RWD) in regulatory submissions would be first seen in limited areas such as rare diseases including rare cancers, Yasuhiro Fujiwara, chief executive of the Pharmaceuticals and Medical Devices Agency (PMDA), said on September 6.…
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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.…





