A look into Risk Evaluation and Mitigation Strategies (REMS) programs and how MVG can help.
MVG Insights: REMS
Monday, April 6, 2020
Risk Evaluation and Mitigation Strategies (REMS) programs were instituted as part of the FDA Amendments Act (FDAAA) in 2007 to provide safe access to products that may not otherwise be approved based on their safety profile. In instances of drug-related safety concerns, REMS may be required by the FDA as a part of the approval of a new product, or even for an already approved product if a safety concern arises. A REMS program requires the involvement of a variety of participants including health care providers, pharmacists, and patients. Drug and biologic applicant holders are tasked with developing these REMS when necessary, which are then submitted to the FDA for approval.
There are currently over 60 active REMS for both individual drugs and classes of drugs. These REMS are typically comprised of “elements to assure safe use” (ETASU) which require clinician or health care setting certification prior to prescribing, “communication plans” which are informative tools used to educate on specific safety risks, and “medication guides” that provide clear drug-related specifications. The FDA periodically inspects REMS programs to ensure that they have been implemented correctly and are functioning in accordance with FDA guidelines. In order to maintain compliance, relevant stakeholders in the drug approval and delivery process are periodically audited.
MVG is a proven partner in REMS audit services, and offers a unique service catered to the specific needs of each client. Unlike typical site audits required throughout the drug development process, which follow clinical practice standards, REMS audits are far more complex. Due to the multitude of players involved, and the requirements necessary for each, the strategy for ensuring compliance must be adequately adaptable to fit each case. Such complexity requires a flexible approach, which MVG has shown continued success in delivering.
For more information on how MVG can become a trusted partner to your company, please contact MVG Consulting Services.
We welcome you to call us at 781-843-5491 or email us at [email protected] to learn how we can help you.
MVG Consulting Services specializes in helping small to medium sized biotechnology and pharmaceutical companies with their clinical development programs and we can provide start-up and virtual companies with the necessary resources to begin their clinical development program.
Services include:
- Clinical Research Consulting Services
- Clinical Trial Development
- Project Rescue
- Inspection Readiness
MVG provides highly qualified clinical research professionals who seamlessly become a part of your project team. Additionally, we provide virtual companies with an entire project team that encompasses all aspects of clinical development.
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