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

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.