http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/Biologics/rss.xml en-us Tue, 23 Jun 2009 02:24:00 UTC cberwebmaster@fda.hhs.gov Thu, 02 Jul 2009 15:01:00 UTC http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ReportaProblem/BiologicalProductDeviations/ucm170290.htm http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ReportaProblem/BiologicalProductDeviations/ucm170290.htm Thu, 02 Jul 2009 15:00:00 UTC http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ReportaProblem/BiologicalProductDeviations/ucm170289.htm http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ReportaProblem/BiologicalProductDeviations/ucm170289.htm Thu, 02 Jul 2009 12:12:00 UTC http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm094073.htm http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm094073.htm Thu, 02 Jul 2009 12:11:00 UTC http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm094055.htm http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm094055.htm Ortho ProVue™, Software Version 3.1 Thu, 02 Jul 2009 12:10:00 UTC http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/SubstantiallyEquivalent510kDeviceInformation/ucm168526.htm http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/SubstantiallyEquivalent510kDeviceInformation/ucm168526.htm Thu, 02 Jul 2009 12:09:00 UTC http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/TissueSafety/ucm168696.htm http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/TissueSafety/ucm168696.htm Defense Blood Standard System (DBSS), version 1.0/1.03 Thu, 02 Jul 2009 12:08:00 UTC http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/SubstantiallyEquivalent510kDeviceInformation/ucm169009.htm http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/SubstantiallyEquivalent510kDeviceInformation/ucm169009.htm Thu, 02 Jul 2009 12:01:00 UTC http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/AdministrativeActionsBiologics/ucm169265.htm http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/AdministrativeActionsBiologics/ucm169265.htm Title 21 Code of Federal Regulations 640.120(a) - The Director, Center for Biologics Evaluation and Research, may approve an exception or alternative procedures to any requirement in subchapter F (Biologics) of Chapter I (Parts 600 - 680) of title 21 of the Code of Federal Regulations regarding blood, blood components or blood products. Both licensed and unlicensed blood establishments must submit requests for an exception or alternative procedure to the requirements in Parts 600-680. Licensed establishments should submit the request in accordance with 21 CFR 601.12 and may reference our guidance document entitled: Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture (July 2001). Thu, 02 Jul 2009 11:59:00 UTC http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/RegulationoftheBloodSupply/ExceptionsandAlternativeProcedures/ucm2005885.htm http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/RegulationoftheBloodSupply/ExceptionsandAlternativeProcedures/ucm2005885.htm Thu, 02 Jul 2009 11:57:00 UTC http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/SubstantiallyEquivalent510kDeviceInformation/ucm169739.htm http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/SubstantiallyEquivalent510kDeviceInformation/ucm169739.htm Fri, 26 Jun 2009 12:04:00 UTC http://www.fda.gov/AboutFDA/CentersOffices/CBER/ucm103202.htm http://www.fda.gov/AboutFDA/CentersOffices/CBER/ucm103202.htm Clinical Investigator Inspection List updated through 6/15/2009. Tue, 16 Jun 2009 16:44:00 UTC http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/ucm165743.htm http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/ucm165743.htm Revised package insert, as well as an information page pertaining to the labeling revision. Mon, 15 Jun 2009 15:10:00 UTC http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm094042.htm http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm094042.htm Information updated through May 31, 2009. Wed, 10 Jun 2009 19:40:00 UTC http://www.fda.gov/BiologicsBloodVaccines/ucm133672.htm http://www.fda.gov/BiologicsBloodVaccines/ucm133672.htm Information updated through May 31, 2009 Wed, 10 Jun 2009 19:39:00 UTC http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/NewDrugApplicationsNDAs/UCM149972 http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/NewDrugApplicationsNDAs/UCM149972 Information updated through May 31, 2009 Wed, 10 Jun 2009 19:37:00 UTC http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/UCM149971 http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/UCM149971 Information updated through May 31, 2009 Wed, 10 Jun 2009 19:37:00 UTC http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/SubstantiallyEquivalent510kDeviceInformation/UCM149975 http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/SubstantiallyEquivalent510kDeviceInformation/UCM149975 510(k) clearance letter and summary. Wed, 10 Jun 2009 19:34:00 UTC http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/SubstantiallyEquivalent510kDeviceInformation/ucm164494.htm http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/SubstantiallyEquivalent510kDeviceInformation/ucm164494.htm