Risk Evaluation & Mitigation Strategy (REMS)

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[1]

Notes

  • program to manage known or potential serious risks associated with a drug product
  • required by the FDA to ensure that the benefits of a drug outweigh its risks

References

  1. ↑ FDA Drug Safety & Avalilability. Aug 8, 2019 Risk Evaluation and Mitigation Strategies | REMS https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems
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