Risk Evaluation & Mitigation Strategies (REMS) with Elements to Assure Safe Use (ETASU)Providing expert support to help manufacturers meet postapproval regulatory commitments for risk assessment and risk minimization
Don’t let the requirement for a Risk Evaluation & Mitigation Strategy (REMS) with Elements to Assure Safe Use (ETASU) slow down your product’s market access. UBC has the depth and breadth of experience to design and implement your REMS with ETASU proactively and efficiently. UBC has designed and implemented more Risk Minimization Action Plans (MAPs) and REMS than any other provider.
Our capabilities include clinical medicine and epidemiology, information technology, regulatory practice, trade relations and distribution logistics, contact center operations, health communications and patient education, and project management.
What is a REMS with ETASU?
The Food & Drug Administration Amendments Act of 2007 (FDAAA) gave FDA the authority to require a REMS from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks. A REMS with ETASU may include risk management processes that require:
- Education and certification of healthcare providers
- Education and certification of those who dispense the product
- Restricting product use only to specified healthcare settings
- Documentation of safe-use condition
- Patient monitoring
- A patient registry
Appropriate patient and healthcare professional education and outreach is critical to a REMS program. In addition to developing Medication Guides and evaluating their effectiveness, UBC has content graphics experts to develop materials for Communication Plans. We have supported 57 programs with one or more elements to assure safe use, with many currently in the marketplace and others under review at the FDA.
Since 2007 when FDAAA went into effect, there have been more than 200 REMS imposed, but fewer than half of those currently remain in the marketplace. Although the FDA is requiring REMS less frequently, when imposed, REMS are more complex and often include elements to assure safe use. In 2015 REMS with ETASU represented 53% of the total number of active REMS.
UBC participates with manufacturers in FDA meetings about designing and implementing REMS, particularly those with ETASU, and we are often asked to address complex analytical and surveillance issues related to REMS on behalf of manufacturers.
Leverage the expertise and experience of UBC to ensure your REMS with ETASU is designed and implemented successfully. Contact us to learn more.