REGULATORY

Sakigake Status Should Not Be Granted to Novartis Products until It Takes Prevention Measures for Approval Delay: Pharma Bureau Chief

September 8, 2020
Mitsuaki Kamata, director general of the Pharmaceutical Safety and Environmental Health Bureau, urged Novartis Pharma to seriously reflect on its flaws in the review process for sakigake-designated Zolgensma (onasemnogene abeparvovec) whose approval was delayed. The company’s products should be made…

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