The FDA has issued a draft guidance on how to notify it of fatalities related to blood collection or transfusion. Physicians may report adverse events by calling (800) FDA-1088 or over the Internet at http://www.fda.gov/medwatch/report/hcp.htm.
The draft, which is open for comments until September 3, 2002, may be requested by calling (800) 835-4709 or (301) 827-1800, or downloaded from the Internet at http://www.fda.gov/cber/guidelines.htm.
Crawford, Jr LM. Proposed Reporting Guidance. JAMA. 2002;288(6):688. doi:10.1001/jama.288.6.688-JFD20008-4-1