REGULATORY
PMDA to Select Products for Sakigake Review; “Probably 5 to 10” Will Be Designated: Official
The Pharmaceuticals and Medical Devices Agency (PMDA) will shortly begin narrowing down a list of products subject to the sakigake designation system for fast-track review, which is being initiated on a trial basis, a PMDA official has recently revealed. Tomonori…
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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…





