Full translation summary from PharmAsia News - November 24, 2008
Find out how the Food and Drug Affairs Bureau at Japan's Ministry of Health, Labor and Welfare revealed a draft of revisions to guidance for medical device good clinical practice.
Full translation summary from PharmAsia News - November 24, 2008
The Food and Drug Affairs Bureau at Japan's Ministry of Health, Labor and Welfare revealed a draft of revisions to guidance for medical device good clinical practice. Regarding composition of independent review boards, the proposal leaves the decision to the president of the trial-conducting facility, but recommends that outside organizations such as non-profit organizations, private medical school hospitals, and national university hospitals should be allowed to participate. To assure transparency, names of IRB members and meeting minutes will be made available to public. The bureau is is collecting public comment on the draft until Dec. 10. (Click here for more - Japanese language)
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