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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The Wednesday TableShe had been on virtual calls since eight in the morning. The screen glowed. Her eyes burned. Plugged into Teams across time zones, she was digitally connected yet entirely isolated from the reality of Japan’s pharma market.She needed…





