Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report)

Susan Najjar

In April 2013 the FDA issued a brief guidance entitled Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report).  This document summarizes FDA’s position on accepting the new format EU/EMA PSURs known as PBRERs.

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