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 Fri, 06 Mar 2009 10:46:00 -0600 cberwebmaster@fda.hhs.gov Fluzone, Fluzone High-Dose and Fluzone Intradermal Tue, 22 May 2012 11:29:00 -0500 http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm112854.htm http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm112854.htm Biologic Product Shortages Mon, 21 May 2012 12:59:00 -0500 http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Shortages/ucm2005969.htm http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Shortages/ucm2005969.htm Complete List of Currently Approved NDA and ANDA Application Submissions Information updated through April 30, 2012 Tue, 08 May 2012 13:22:00 -0500 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, 2012 Tue, 08 May 2012 13:21:00 -0500 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, 2012 Tue, 08 May 2012 13:19:00 -0500 http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/SubstantiallyEquivalent510kDeviceInformation/UCM149975.pdf http://www.fda.gov 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, 07 May 2012 14:20:00 -0500 http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm103202.htm http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm103202.htm Cord Blood Banking Information for Consumers Mon, 07 May 2012 13:15:00 -0500 http://www.fda.gov/BiologicsBloodVaccines/ResourcesforYou/Consumers/ucm236044.htm http://www.fda.gov/BiologicsBloodVaccines/ResourcesforYou/Consumers/ucm236044.htm Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 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. Tue, 01 May 2012 07:53:00 -0500 http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/RegulationoftheBloodSupply/ExceptionsandAlternativeProcedures/ucm2005885.htm http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/RegulationoftheBloodSupply/ExceptionsandAlternativeProcedures/ucm2005885.htm List of Establishments Granted Approval for a Variance to 21CFR640.3(d) and 21CFR640.3(f) Tue, 01 May 2012 06:51:00 -0500 http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/RegulationoftheBloodSupply/Variances/ucm164649.htm http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/RegulationoftheBloodSupply/Variances/ucm164649.htm