REGULATORY
MHLW Issues Notification to Spur Use of RWD in Place of Clinical Trial Data
The Ministry of Health, Labor and Welfare (MHLW) issued a notification on October 4 outlining points to note when companies seek partial modifications of approval using registry data on patients’ diseases, treatment details, and follow-up results. The aim of the…
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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…





