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Document of the Week...

REMS Adequacy: Mifiprex

The Government Accountability Office released this report in 2018 in response to Congressional concerns about the adequacy of postmarketing safety monitoring of Mifiprex. This document describes the FDA;s monitoring of the safety and use of the drug, offering an interesting examination of the Risk Evaluation and Mitigation Strategy for an FDA-approved product which carries political baggage. Contents address approval data, inspectional history, adverse events and assessment of stakeholder organization views.

Featured until November 12, 2019. Click here to download.