REGULATORY
PMDA to Focus on Proper Use of Sakigake and Conditional Approval Systems in Its 4th Midterm Plan
The Pharmaceuticals and Medical Devices Agency (PMDA) will focus on the proper use of the sakigake fast-track designation scheme and the conditional early approval system in its fourth midterm plan starting April next year, the agency revealed on October 17.…
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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…





