From GRP to SIUU – the Evolution of FDA Guidance on Off-Label Dissemination of Scientific Information
FDA Law Blog
OCTOBER 24, 2023
Previous iterations of this guidance from 2009 and 2014 (blogged on here and here ) were known as Good Reprint Practices (GRP). Throughout the SIUU Guidance, FDA refers to studies and analyses , suggesting that publications may cover more than a description of an adequate and well-controlled clinical trial.
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