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Proposed Reporting Guidance

Proposed Reporting Guidance The FDA has issued a draft guidance on how to notify it of fatalities related to blood collection or transfusion.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. Written inquiries may be directed to Office of the Commissioner of Food and Drugs, HF-1, Room 14-71, 5600 Fishers Ln, Rockville, MD 20857. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

Proposed Reporting Guidance

Jr, Lester M. Crawford,
JAMA , Volume 288 (6) – Aug 14, 2002
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1 page

Proposed Reporting Guidance

Abstract

The FDA has issued a draft guidance on how to notify it of fatalities related to blood collection or transfusion.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. Written inquiries may be directed to Office of the...
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Publisher
American Medical Association
Copyright
Copyright © 2002 American Medical Association. All Rights Reserved.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.288.6.688-JFD20008-4-1
Publisher site
See Article on Publisher Site

Abstract

The FDA has issued a draft guidance on how to notify it of fatalities related to blood collection or transfusion.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. Written inquiries may be directed to Office of the Commissioner of Food and Drugs, HF-1, Room 14-71, 5600 Fishers Ln, Rockville, MD 20857.

Journal

JAMA – American Medical Association

Published: Aug 14, 2002

Keywords: blood specimen collection,internet,transfusion,medwatch,adverse event,guidelines

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