Format and Content of a REMS Document

The FDA published a guidance on the format and content of a risk evaluation and mitigation strategy (REMS) document for prescription drug products, including biological drugs. Additional and more detailed information is provided in a separate guide that includes a REMS Document Template. If the agency determines that a REMS is necessary (see FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary), one or more REMS elements may be required (e.g., medication guide, patient package insert, communication plan). The FDA may also require elements to assure safe use (ETASU). These elements may include one or any combination of the following requirements:

  • Health care providers who prescribe the drug have particular training or experience, or are specially certified,
  • Pharmacies, practitioners, or health care settings that dispense the drug are specially certified,
  • The drug be dispensed to patients only in certain health care settings (e.g. hospitals) and/or with evidence of safe use conditions (e.g. laboratory test results),
  • Patients using the drug be subject to monitoring and/or be enrolled in a registry.

REMS Assessment and Submission

According to the FDA, REMS generally must include a timetable for submission of assessments. The timetable must include an assessment by the dates that are 18 months and 3 years after the REMS is initially approved, and an assessment in the 7th year after the REMS is approved (or at another frequency specified in the REMS). A proposed REMS can be included in the initial submission of an original or supplemental application, or submitted as an amendment to an existing application. All supplemental applications that include a new proposed REMS should be submitted as prior approval supplements (PAS). A proposed REMS submitted after product approval and not associated with an existing supplemental application should be submitted as a new supplemental application.

All approved REMS documents and their approved REMS materials are posted on the FDA’s website. More Information is available in FDA´s Guidance Documents Format and Content of a REMS Document and REMS Document Technical Conformance.

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