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)
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FDA Basics Webinar: A Brief Overview of REMS(PDF - 1.2MB)
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- FDA Basics Metrics: April 2013
- When and why was FDA formed?
- How does FDA provide information about drug products currently under review for approval by the agency?
- Why are some drugs available as both a prescription and an over-the-counter drug?
- What does FDA do?
- What Should I Do If I See Violations of FDA’s Tobacco Products Rules?
- FDA Center for Tobacco Products Inaugural Year and Looking Forward
- What are FDA’s Regulations for Flavored Tobacco?
- What are the new Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents?
- What will FDA do to curb tobacco use among children and adolescents?
- What are some of the key regulatory timelines associated with the tobacco control act?
- How does the regulation of tobacco products differ from FDA’s regulation of drugs or medical devices?
- Is FDA going to ban tobacco?
- What products are not considered to be tobacco products as defined by the tobacco control act?
- What products are considered to be tobacco products as defined by the tobacco control act?
- What is the main goal in regulating tobacco products?
- What are the priorities of the Center for Tobacco Products?
- Does FDA have the authority to regulate tobacco products?
- What does FDA inspect?
- How is FDA organized?
- What does FDA regulate?
- FDA Basic Video: Lawrence Deyton Discusses Tobacco (Video)
- What part of FDA regulates tobacco products?
- FDA Basics Metrics: March 2013
- Upcoming Webinar Tuesday, March 19th - Buyer Beware:The Risks and Dangers of Purchasing Drugs Online
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