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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I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…





