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

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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. § 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

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http://www.biosciencetechnology.com/News/Feeds/2010/06/sections-regulatory-news-peramivir-emergency-use-authorization-disposition-/