This List presents a comprehensive source of references for statistical guidance documents and related articles that are relevant to regulatory affairs for those statisticians that work on clinical studies. The List is associated with the Wikipedia page Guidances for statistics in regulatory affairs that aims to address the various topics of the listed guidances. Regulatory guidances (draft and/or final ) are subject to revisions. Therefore, users of the guidances are advised to consult the original website to check for the latest version. Users are also encouraged to update the Wikipedia List.
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