Documents recently posted on the CBER Web Site http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/Biologics/rss.xml en-us Thu, 03 Sep 2009 12:05:00 -0400 cberwebmaster@fda.hhs.gov Thu, 03 Sep 2009 12:05:00 -0400 http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm181291.htm http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm181291.htm Information updated through October 31, 2009 Fri, 08 May 2009 22:50:00 -0400 http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/NewDrugApplicationsNDAs/UCM149972 http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/NewDrugApplicationsNDAs/UCM149972 Information updated through October 31, 2009 Fri, 08 May 2009 22:33:00 -0400 http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/UCM149971 http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/UCM149971 Information updated through October 31, 2009 Sat, 09 May 2009 01:14:00 -0400 http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/SubstantiallyEquivalent510kDeviceInformation/UCM149975 http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/SubstantiallyEquivalent510kDeviceInformation/UCM149975 Thu, 19 Nov 2009 14:39:00 -0500 http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/BloodDonorScreening/BloodGroupingReagent/ucm191407.htm http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/BloodDonorScreening/BloodGroupingReagent/ucm191407.htm Vaccine lot release information updated on 11/18/2009. Thu, 28 May 2009 13:06:00 -0400 http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Post-MarketActivities/LotReleases/ucm162050.htm http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Post-MarketActivities/LotReleases/ucm162050.htm Vaccine lot release information updated on 11/18/2009. Tue, 15 Sep 2009 15:59:00 -0400 http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Post-MarketActivities/LotReleases/ucm181956.htm http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Post-MarketActivities/LotReleases/ucm181956.htm Information updated through October 31, 2009 Mon, 13 Apr 2009 12:34:00 -0400 http://www.fda.gov/BiologicsBloodVaccines/ucm133672.htm http://www.fda.gov/BiologicsBloodVaccines/ucm133672.htm PREA Labeling Changes, Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA). These assessments are for CBER regulated drugs approved under section 505 of the Act and biological drugs licensed under section 351 of the Public Health Service Act. Wed, 18 Mar 2009 15:33:00 -0400 http://www.fda.gov/AboutFDA/CentersOffices/CBER/ucm122938.htm http://www.fda.gov/AboutFDA/CentersOffices/CBER/ucm122938.htm 11/13/2009 Fri, 13 Nov 2009 06:20:00 -0500 http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM190373 http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM190373 510(k) clearance letter and summary. Fri, 05 Jun 2009 15:32:00 -0400 http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/SubstantiallyEquivalent510kDeviceInformation/ucm164494.htm http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/SubstantiallyEquivalent510kDeviceInformation/ucm164494.htm Tue, 30 Jun 2009 10:20:00 -0400 http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/SubstantiallyEquivalent510kDeviceInformation/ucm169739.htm http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/SubstantiallyEquivalent510kDeviceInformation/ucm169739.htm The Bone Marrow Collection Kit, Ancillary Container, and Bone Marrow Collection Stand are used for the collection and filtration of aspirated bone marrow in preparation for bone marrow transplantation. Fri, 07 Aug 2009 12:52:00 -0400 http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/SubstantiallyEquivalent510kDeviceInformation/ucm176238.htm http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/SubstantiallyEquivalent510kDeviceInformation/ucm176238.htm Wed, 25 Feb 2009 08:23:00 -0500 http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm094043.htm http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm094043.htm Tue, 13 Oct 2009 09:46:00 -0400 http://www.fda.gov/BiologicsBloodVaccines/Vaccines/QuestionsaboutVaccines/ucm186102.htm http://www.fda.gov/BiologicsBloodVaccines/Vaccines/QuestionsaboutVaccines/ucm186102.htm The purpose of this document is to provide guidance to CBER staff on the policies and procedures for the binding of regulatory documents submitted to CBER. This guidance will permit CBER staff to provide information to applicants and sponsors planning on submitting documents for regulatory action and will expedite the handling of submissions when received. Tue, 03 Mar 2009 12:09:00 -0500 http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ProceduresSOPPs/ucm109596.htm http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ProceduresSOPPs/ucm109596.htm Substantially Equivalent 510(k) submission; cleared 11/10/2009 Fri, 13 Nov 2009 14:16:00 -0500 http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/SubstantiallyEquivalent510kDeviceInformation/ucm190250.htm http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/SubstantiallyEquivalent510kDeviceInformation/ucm190250.htm Tue, 10 Nov 2009 17:30:00 -0500 http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm189907.htm http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm189907.htm The supplements are listed by date of approval, with the most recent action at the top. Tue, 14 Jul 2009 14:29:00 -0400 http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/BiologicalApprovalsbyYear/ucm167932.htm http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/BiologicalApprovalsbyYear/ucm167932.htm This list reflects information regarding the applications as of the approval date. Tue, 08 Sep 2009 10:49:00 -0400 http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/BiologicalApprovalsbyYear/ucm167930.htm http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/BiologicalApprovalsbyYear/ucm167930.htm