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 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.
Has this event been cancelled?
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Is this going to be added to youtube?
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Are these presentations uploaded to be viewed?
How are the REMS actually enforced if there is a new one for every “safety risk” product out there?
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Thanks for the info. It’s really dificult to track down reliable and informed comment regarding safely and in particular the current stategy.
It is like the French programme? I think they have something similar.
Thank you for that info and webinar, very valuable.
great article with great information.
REMS should include a medication guide, a patient package insert, a communication plan, elements to assure safe use, and an implementation system. Does all REMS programs will contain a timetable for assessment?
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Please let us know if youll post the recorded webinar on the site. We’d love to know
No new transparency posts since October?
What is the status of the Phase II transparency proposals (Public Disclosure)?
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It would be great if the presentations were recorded and available for viewing at a later time.
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Is this going to happen again?
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Re the text / IE issue noted above – text is working fine for us over here in Manchester and not running off the website page! (Firefox).
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Nice information, and thanks a lot.
It was a very interesting presentation, will it be put on youtube at any point?