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    Additional copies of this guidance are available from the Office of Communication, Outreach and Development (OCOD), (HFM-40), 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448, or by calling 1-800-835-4709 or 301-827-1800, or e-mail [email protected], or from the Internet at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. For questions on the content of this guidance, contact OCOD at the phone…

January 13, 2010 What information did FDA use to support the approval of the Intranasal Influenza A (H1N1) 2009 Monovalent Live Attenuated Vaccine? Vaccines used in the United States must be licensed by FDA.  FDA approved all of the Influenza A (H1N1) 2009 vaccines as a strain change to each manufacturer’s FDA-approved seasonal influenza vaccine….

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Date(s) And Time(s):Mar 22, 2010 8:00AM – Mar 23, 2010 5:00PM Location:Bethesda North Marriott Hotel and Conference Center5701 Marinelli RoadNorth Bethesda, MD 20852  Drug Information Association (DIA) Registration and Meeting Information Interest Area(s): CMC, Clinical Research, Clinical Safety/Pharmacovigilance, Nonclinical, Regulatory Affairs, Research Development, Statistics Overview: FDA Forum to Promote Progress in Computational Science from Regulatory and Product…

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