Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
COMMENTARY
Data from Humanitarian Trials to Be Used in Product Reviews; Effective Use of Safety-Related Information Will Be Key
A basic plan for so-called “humanitarian trials,” or a Japanese version of the compassionate use system, was announced in September. The plan would permit expanded access to new drugs following domestic “main studies,” or during such studies (after patient enrollment…
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COMMENTARY
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