Module 1.6 REMS Submissions

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This module provides a more in-depth overview of the end-to-end process for developing, preparing, and submitting Risk Evaluation and Mitigation Strategy (REMS) submissions to the FDA. It outlines the four primary phases (initiation, strategic planning, document preparation, and submission) and explains the detailed requirements associated with each. Participants learn about each component of the REMS document, developing REMS materials and supporting documentation, and understanding the distinctions among initial REMS, bifurcated REMS, and single shared system REMS. The module also covers regulatory pathways for REMS updates, including revisions, minor modifications, and major modifications, and provides guidance on submission formats (including SPL), expectations for responding to FDA information requests, and timelines for FDA review and action.