SUMMARY

The FDA may require Risk Evaluation and Mitigation Strategies (REMS) and Elements to Assure Safe Use (ETASU) for drugs with specific safety concerns. REMS and ETASU are designed to identify, mitigate, and manage risks associated with certain pharmaceutical products. They help ensure that the benefits of the drug outweigh potential risks, contributing to overall patient safety. While ensuring patient safety, REMS and ETASU also aim to avoid unnecessary restrictions that could hinder patient access to essential medications. The creation of Risk Evaluation and Mitigation Strategies (REMS) and Elements to Assure Safe Use (ETASU) can take three forms: De Novo, Single-Shared System (SSS), and Updates and Modifications. Balancing safety measures with the need for timely access is a key consideration in the development of these strategies. These risk management strategies often involve communication and educational efforts directed at healthcare providers, patients, and other stakeholders. The development of REMS and ETASU involves collaboration with the FDA to align risk management efforts with regulatory expectations. This collaborative approach helps foster transparency and compliance with regulatory requirements. A comprehensive development approach involves Knowledge, Attitude, and Behavior (KAB) testing. The timeline and KPI for development varies depending on the type and extent of the work undertaken.