Home > Uncategorized > FDA Basics Webinar: A Brief Overview of Risk Evaluation and Mitigation Strategies (REMS)

FDA Basics Webinar: A Brief Overview of Risk Evaluation and Mitigation Strategies (REMS)

October 23, 2012 Leave a comment Go to comments

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.

  1. karma
    October 30, 2012 at 5:05 pm

    Has this event been cancelled?

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    November 7, 2012 at 10:23 am

    Nice information, and thanks a lot.

  5. Ashley
    November 17, 2012 at 12:47 am

    Is this going to be added to youtube?

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    Are these presentations uploaded to be viewed?

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    November 18, 2012 at 5:32 am

    How are the REMS actually enforced if there is a new one for every “safety risk” product out there?

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    November 28, 2012 at 6:26 am

    thanks for share,,,,

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    November 29, 2012 at 12:29 pm

    Really great presentation, there is so much ignorance about this topic, and it’s really important for everyone of us, very nice work!!

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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.

  12. Flavius
    December 6, 2012 at 4:14 pm

    It is like the French programme? I think they have something similar.

  13. Bigos
    December 9, 2012 at 6:56 pm

    Thank you for that info and webinar, very valuable.

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    December 28, 2012 at 11:08 am

    great article with great information.

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    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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    January 31, 2013 at 6:46 pm

    Please let us know if youll post the recorded webinar on the site. We’d love to know

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    No new transparency posts since October?

    What is the status of the Phase II transparency proposals (Public Disclosure)?

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