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From the Food and Drug Administration
August 14, 2002

Proposed Reporting Guidance

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JAMA. 2002;288(6):688. doi:10.1001/jama.288.6.688-JFD20008-4-1

The FDA has issued a draft guidance on how to notify it of fatalities related to blood collection or transfusion.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.

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