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 will be held on November 20, 2012 at 1:00 PM EST and will discuss REMS and how they are used to help ensure that the benefits of certain medicines continue to outweigh their risks. To join the meeting, click here: https://collaboration.fda.gov/rems1/
For more information, visit the FDA Basics website.