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 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 Friday, May 23 - Packing A Healthy Lunch
- 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?
- FDA Basics Metrics: August 2014
- FDA Basics Metrics: July 2014
- FDA Basics Metrics: June 2014
- Where do I go to report problems with flea and tick products?
- What does FDA regulate?
- FDA Basics Metrics: May 2014
- FDA Basics Metrics: April 2014
- Who can I contact if my question wasn’t answered or I have additional questions in the future?
- FDA Basics Metrics: March 2014
- FDA Basics Metrics: February 2014
- What is the Reportable Food Registry?
How helpful was this information?