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
- Vaccines for Use During Pregnancy to Protect Young Infants from Disease – FDA Update
- FDA Basics Webinar: Practice the art of sun protection
- FDA Basics Webinar: "Mini-Sentinel," FDA's New Tool for Monitoring the Safety of FDA-Approved Medical Products
- FDA Basics Webinar - April 27, 2015: Drug Trials Snapshots
- FDA Webinar on Prescription Drug Shortages
- When previously recalled products are back on the shelves, how can I be sure that it is okay to buy them?
- What do consumers need to know about the recall of shell eggs?
- What is FDA Basics for Industry?
- FDA Basics Webinar- August 31, 2015: Food Safety: Bad Weather Basics
- July: CBER's Direct Recall Classification Program
- FDA Basics Webinar, June 17, 2013: Biological Products: Part 1
- Is it true that "OTC (Over the Counter)" products can prevent SIDS?
- FDA's Pesticide Program
- Recall Process for FDA-Regulated Products
- Where can I find information about adverse reactions to a medicine prescribed for my child?
- Where can I find information about medicines prescribed for my child?
- FDA Webinar on Protecting Your Child's Health Through Safe and Effective Vaccines
- FDA Webinar on Safety of the Blood Supply
- How did the Federal Food, Drug, and Cosmetic Act come about?
- Materials from Webinar on Access to Investigational Drugs
- How do I find the latest information on the Web site? How do I sign up for e-mails and alerts?
- What is a docket? How do I submit comments to a docket? How do I find comments submitted to a docket?
- Can I buy medical products online? How do I know they're safe?
- FDA Basics Webinar: FDA CBER Mini-Sentinel Program
- FDA Basics Webinar - November 24, 2014: Drug Shortages