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REMS Statutory Factors Weighed On Case-By-Case Basis, US FDA Says

 
• By Sue Sutter

US FDA rebuffs PhRMA’s request to clarify how the six statutory factors are weighed and to explain how it decides what a REMS should look like. All six factors are considered together to inform agency’s decision-making on the need for a Risk Evaluation and Mitigation Strategy, according to final version of guidance first issued in 2016.

Risk mitigation text concept write on notebook with pen

The relative importance of each of six statutory factors is a case-specific inquiry in determining whether a Risk Evaluation and Mitigation Strategy (REMS) is needed to ensure that a drug’s benefits outweigh its risks, the US FDA says in a new guidance.

Despite industry requests to clarify which, if any, of the six factors carries greater weight in FDA’s determination about the...

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