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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In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…





