What's New: Vaccines, Blood & Biologics RSS Feed Documents recently posted on the CBER Web Site http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/Biologics/rss.xml en-us Wed, 13 Jan 2010 16:54:00 -0500 cberwebmaster@fda.hhs.gov Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal Questions and Answers Fri, 24 May 2013 09:43:00 -0400 http://www.fda.gov/BiologicsBloodVaccines/Vaccines/QuestionsaboutVaccines/ucm197513.htm http://www.fda.gov/BiologicsBloodVaccines/Vaccines/QuestionsaboutVaccines/ucm197513.htm Jobs at the Center for Biologics Evaluation and Research (CBER) Interdisciplinary Scientist, Closes: 4/23/2010; Supervisory Contract Specialist (Direct Hire), Closes: 12/31/2010 Mon, 20 May 2013 01:11:00 -0400 http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm103202.htm http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm103202.htm Procleix Ultrio Assay Mon, 20 May 2013 01:07:00 -0400 http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/BloodDonorScreening/InfectiousDisease/ucm092027.htm http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/BloodDonorScreening/InfectiousDisease/ucm092027.htm Kcentra (Prothrombin Complex Concentrate, Human) Approval Letter and Product Labeling, Posted: 4/30/2013 Thu, 16 May 2013 10:04:00 -0400 http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm350130.htm http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm350130.htm Phlebotomy System 1.0.0 Thu, 09 May 2013 13:04:00 -0400 http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/SubstantiallyEquivalent510kDeviceInformation/ucm351393.htm http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/SubstantiallyEquivalent510kDeviceInformation/ucm351393.htm Indication For Use - SOLX® System Thu, 09 May 2013 10:10:00 -0400 http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/NewDrugApplicationsNDAs/UCM349830.pdf http://www.fda.gov Complete List of Currently Approved NDA and ANDA Application Submissions Information updated through April 30, 2013 Tue, 07 May 2013 14:20:00 -0400 http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/NewDrugApplicationsNDAs/UCM149972.pdf http://www.fda.gov Complete List of Currently Approved Premarket Approvals (PMAs) Information updated through April 30, 2013 Tue, 07 May 2013 14:17:00 -0400 http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/UCM149971.pdf http://www.fda.gov Complete List of Substantially Equivalent 510(k) Device Applications Information updated through April 30, 2013 Tue, 07 May 2013 14:14:00 -0400 http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/SubstantiallyEquivalent510kDeviceInformation/UCM149975.pdf http://www.fda.gov List of Establishments Granted Approval for a Variance to 21CFR640.3(d) and 21CFR640.3(f) Mon, 06 May 2013 10:55:00 -0400 http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/RegulationoftheBloodSupply/Variances/ucm164649.htm http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/RegulationoftheBloodSupply/Variances/ucm164649.htm Cord Blood Licensure: A Workshop March 8 - 9, 2010 Mon, 06 May 2013 08:06:00 -0400 http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm198942.htm http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm198942.htm DIA/FDA CDER/CBER Computational Science Annual Meeting This meeting will review progress on topics such as data standards, best practices-driven analytical tool development, business processes driving information systems development, and user experience/evaluation of current tools. Mon, 06 May 2013 08:05:00 -0400 http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm203146.htm http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm203146.htm Biologic Product Shortages A biological product shortage occurs when a biological product is not commercially available in sufficient quantity to meet the demand. Thu, 25 Apr 2013 12:40:00 -0400 http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Shortages/ucm2005969.htm http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Shortages/ucm2005969.htm