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Amarin Corporation plc Message Board

  • ski8688 ski8688 Oct 1, 2013 11:13 AM Flag

    PDUFA and AdCom are on!

    PDUFA (and AdCom) will go on as scheduled, per FDA:

    "Information for Industry (Drugs)
    [10/1/2013] In the absence of either an FY 2014 appropriation or a Continuing Resolution for FDA, beginning on October 1 and continuing until the date of enactment of an FY 2014 appropriation or Continuing Resolution ("lapse period"), agency operations will be limited to the following:
    -Emergency work involving the safety of human life or the protection of property;
    -Criminal law enforcement work; and
    -Activities funded by carryover user fee balances, including user fee balances under the Prescription Drug User Fee Act (PDUFA), Generic Drug User Fee Amendments (GDUFA), Medical Device User Fee Amendments (MDUFA), Animal Drug User Fee Act (ADUFA), Animal Generic Drug User Fee Act (AGDUFA), and Family Smoking Prevention and Tobacco Control Act. Carryover user fee balances will only be spent on activities for which the fees are authorized under the Federal Food, Drug, and Cosmetic Act (FD&C Act)."

    Sentiment: Strong Buy

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