Risk Evaulation & Mitigation Strategies (REMS)
Not an obstacle – an opportunity.
Don’t look at Risk Evaluation Mitigation Strategies (REMS) as an obstacle – look at them as an opportunity for faster FDA approval. The FDA focus on risk requires that manufacturers bear responsibility for the safety of a new drug or biological product. When you’re developing a drug, the FDA may require manufacturers to produce information that illustrates how the benefits of your product outweigh the associated risks.
REMS Elements
We can help guide you through the REMS and risk mitigation process with advice such as:
- Take a cross-functional approach, if it is determined that a REMS is necessary
- Involve your finance department and evaluate costs for REMS solutions – are they fiscally responsible?
- Work with a trusted partner such as Centric Health Resources that features experts who understand FDA terminology and mandates
- Be sure you can actually implement a REMS program that you design. The FDA will hold you to your word.
- Have a detailed informational plan in your FDA submission. The fewer questions you leave open, the smoother the process will flow.
Rely on Centric Health Resources as your trusted partner for REMS and risk mitigation and give your product the best opportunity for FDA approval.
