Risk Evaluation & Mitigation Strategy (REMS)

Risk Evaluation and Mitigation Strategy (REMS) for FDA Compliance

In 2007, the FDA mandated that drug and biologic manufacturers submit a Risk Evaluation and Mitigation Strategy (REMS) to manage known or potentially dangerous risks associated with their products.

The FDA Amendments Act of 2007 (FDAAA) states that the FDA may either impose a REMS as a condition for a new product approval, or retroactively for a product that has been previously approved. This post-approval requirement may occur if the FDA identifies safety information and deems that a REMS is necessary.

ClinAudits assures navigation and guidance for compliance with the FDA Amendments Act of 2007 (FDAAA) requirements:

  • Patient package or med-guide insert
  • Medication guide
  • Implementation system
  • Communication plan
  • Effectiveness timetable assessment
  • Elements to assure safe use (*ETASU)
  • Audits of pharmacies
  • Audits of REMS vendors including but not limited to call centers, print/mail vendors, print fulfillment vendors, drug master file holders, pregnancy registry vendors, FDA report vendors, patient/prescriber survey vendors, documentation vendors and program oversight vendors.

*ETASU: a REMS may require that prescribers and dispensers of the drug or biological may be required to have certain training, experience, and/or certification

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