The document provides guidance to applicants submitting investigational new drug applications (INDs), new drug applications (NDAs), biologics license applications (BLAs), or supplemental applications on the use of meta-analyses of randomized controlled clinical trials (RCTs) to evaluate the safety of human drugs or biological products within the framework of regulatory decision-making.

To read the draft go the pdf..

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  • John Doe Reply

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    November 12, 2017 at 1:38 pm

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