While Japan has now granted its first emergency approval to Shionogi’s COVID-19 pill Xocova (ensitrelvir), the drug failed to win a unanimous vote by advisory panels, with skepticism lingering over its actual efficacy. To prep for the next emergency, which…
REGULATORY
Products Filed for Conditional OK Can Be Switched to Emergency Approval: MHLW Official
It would be possible to apply the proposed emergency approval pathway to products that have already been filed for conditional early approval if a bill to amend the Pharmaceuticals and Medical Devices (PMD) Law is enacted and enforced, a senior…
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