The Ministry of Health, Labor and Welfare (MHLW) on November 29 proposed a more stringent application of the current 40% entry price rule for first oral generics towards the FY2024 drug pricing reform.Under the current rule, first oral generics are…
COMMENTARY
After Death in First-in-Human Study, MHLW Needs to Release Info. to Alleviate Concerns about Participation in Studies
An adult man who completed the administration of an investigational drug in a Japan PI study conducted by Eisai has died. Whether there was a causal relationship between the drug and the subject’s death remains unclear at the present time,…
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