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FDA: Peramivir Emergency Use Authorization Disposition Letter and Question and Answer Attachment

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  • FDA: Peramivir Emergency Use Authorization Disposition Letter and Question and Answer Attachment

    Peramivir Emergency Use Authorization Disposition Letter and Question and Answer Attachment

    Featured In: Regulatory News
    By Federal Drug Administration Tuesday, June 22, 2010


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    Peramivir Emergency Use Authorization Disposition Letter and Question and Answer Attachment

    HHS LogoDEPARTMENT OF HEALTH AND HUMAN SERVICES

    Food and Drug Administration

    Silver Spring MD 20993


    June 22, 2010



    Thomas R. Frieden, MD, MPH

    Director

    Centers for Disease Control and Prevention

    1600 Clifton Rd., MS D-14

    Atlanta, GA 30333



    Re: Disposition of Peramivir



    Dear Dr. Frieden:



    This letter responds to your request regarding the disposition of peramivir upon termination of the authorization of emergency use that was issued on October 23, 2009, pursuant to section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. ยง 360bbb-3. Attached are Questions and Answers Regarding Termination of the Emergency Use Authorization for Peramivir IV.



    Sincerely,

    _____________________________
    Margaret Hamburg, M.D.
    Commissioner of Food and Drugs


    ATTACHMENT

    Questions and Answers for Hospitals and Healthcare Professionals Regarding Termination of the Emergency Use Authorization for Peramivir IV

    ...


    http://www.biosciencetechnology.com/...-disposition-/
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