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Thread: Risk Evaluation and Mitigation Strategies (REMS)

  1. #1
    PharmD Year 1 TomHsiung's Avatar
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    Default Risk Evaluation and Mitigation Strategies (REMS)

    This is the FDA official website of Risk Evaluation and Mitigation Strategies (REMS).

    URL: http://www.fda.gov/Drugs/DrugSafety/...tm#information

    The Food and Drug Administration Amendments Act of 2007 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.

    Risk Evaluation and Mitigation Strategies (REMS)-fda-rems-jpg
    Last edited by TomHsiung; Sat 13th April '13 at 6:03pm.

  2. #2
    Pre-pharmD Year 1
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    I read about REMS and found ER/LA opioids are highly potent drugs that are approved to treat moderate to extreme persistent pain for serious and chronic conditions (list of ER/LA opioid products). Usually misuse and abuse of these drugs have resulted in a serious public health crisis of addiction, overdose, and death and the REMS is part of a multi-agency Federal work to address the growing issue of prescription drug abuse and misuse.because the REMS introduces new safety measures to reduce risks and improve safe use of ER/LA opioids while continuing to provide access to these medications for patients in pain.
    Last edited by WebmasterJames; Wed 13th November '13 at 3:12pm.

  3. #3
    PharmD Candidate
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    Yeah it should be as less as possible because having some sort of risk causes inappropriate effects on our health,So it should be treated in the right way liking it dude and appreciate your effort.


    Nitin Chhoda

  4. #4
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    A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage potential serious risks connected with a drug product and is required by the FDA to confirm that the benefits of a drug outweigh its uncertainty. It also so pharmacy training program.

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