FDA Basics Webinar: A Brief Overview of Risk Evaluation and Mitigation Strategies (REMS)
In 2007, a new law that gave FDA many new authorities and responsibilities to enhance drug safety was enacted. It's called the Food and Drug Administration Amendments Act- sometimes called "FDAAA"- and one of its provisions gave FDA the authority to require a Risk Evaluation and Mitigation Strategy-(REMS) from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks.
A REMs may be required by the FDA as part of the approval of a new product, or for an approved product when new safety information arises. Essentially, a REMS is a safety strategy to manage a known or potential serious risk associated with a medicine and to enable patients to have continued access to such medicines by managing their safe use.
Since medicines are very different from each other, each REMS for each medicine is also different.
This presentation discussed REMS and how they are used to help ensure that the benefits of certain medicines continue to outweigh their risks.
A Brief Overview of Risk Evaluation and Mitigation Strategies (REMS)
Adobe Connect link
FDA Basics Webinar: A Brief Overview of REMS(PDF - 1.2MB)
Download Presentation Slides
- FDA Basics Webinar - April 27, 2015: Drug Trials Snapshots
- Webinar Friday, May 23 - Packing A Healthy Lunch
- How can I share my ideas and suggestions with FDA?
- FDA Basic Video: Terry Toigo Talks About Helping Patients and their Families (Video)
- Where should I go to find consumer information on www.FDA.gov?
- Does FDA regulate dietary supplements for animals?
- Webinar: 20 Years Later – Returning to FDA to Regulate Tobacco
- Connect with Us: Using FDAs Digital Tools to Present, Participate and Personalize Tobacco Information
- FDA Center for Tobacco Products Inaugural Year and Looking Forward
- FDA Basics Metrics: February 2015
- FDA Basics Metrics: January 2015
- What are Veterinary Biologics (including vaccines) and is FDA responsible for these products?
- FDA Basics Metrics: December 2014
- FDA Basics Webinar: FDA CBER Mini-Sentinel Program
- Recall Process for FDA-Regulated Products
- FDA Basics Metrics: November 2014
- FDA Basics Webinar - November 24, 2014: Drug Shortages
- FDA's MedWatch Program: Voluntarily Reporting Problems to the FDA
- FDA Basics Webinar June 30, 2014: Over-The-Counter Medicines and Driving
- Webinar Tuesday, May 13 - Temporary Tattoos: Raising Consumer Awareness of Safety
- FDA Basics Webinar November 5, 2014: CVM’s Pet Food Reporting and Recall Process
- FDA Basics Metrics: October 2014
- FDA Basics Metrics: Septemeber 2014
- Who can I contact if my question wasn’t answered or if I have additional questions in the future?
- What Should I Do If I See Violations of FDA’s Tobacco Products Rules?
How helpful was this information?