FDA-CBER

• Site Map
• Guidances / Guidelines / Points to Consider
• Blood Guidances
• Workshops & Open Public Meetings
• Organizational Information
• Notification Process for Transfusion Related Fatalities and Donation Related Deaths
• Biological Product Deviation Reporting (BPDR)
• Error & Accident Reports (also see related UK site "SHOT")
• 2006 21CFR606 (Good Manufacturing Practices for Blood) Available as text or PDF files. Also search CFR online.
• FDA Enforcement Report Index
• Circular of Information (PDF file) Includes Final Guidance of December 2003 for COI dated July 2002. Also see Circulars of Information on AABB Website, which includes interim wording for facilities using a licensed WNV test system.
• Guidance for Industry: Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels (FDA/CBER) Also see: United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128 (ICCBBA, Nov. 2005, Version 2.0.0)

CDC

• Main Site
• Malaria countries
• MMWR
• BaCon Study

OTHER

• Dept of Health & Human Services Advisory Committee on Blood Safety and Availability
• Armed Services Blood Program Please note: The ASBP Standardized Donor Deferral Lists are no longer available in the public area of the ASBP Web site. These lists are provided as guidance to military blood collection centers and are now accessible only to military staff members. (last updated Feb. 2007)
• CDER Medication Errors
• Federal Register