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FDA Releases Draft Guidance Updating Warnings for Labeling of Albumin, Highlighting Risk of Creutzfeldt Jakob Disease

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On June 11, 2012, the U.S. Food and Drug Administration (“FDA”) published a draft guidance document, entitled Draft Guidance for Industry: Amendment to ‘Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products.’ Found here, the Document highlights the recommended changes to labeling in light of current scientific knowledge. Creutzfeldt-Jakob Disease (“CJD”) is a debilitating brain disorder that results in rapidly declining neurological functioning and ultimately death. Related to bovine spongiform encephalitis (“BSE” or “Mad Cow Disease”), variant Creutzfeldt-Jakob Disease (“vCJD”) is extremely rare and thought…
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FDA Issues Statement on USDA BSE (“mad-cow”) Case

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On April 26, 2012, the U.S. Food and Drug Administration (“FDA”) issued a statement concerning the recent announcement confirming a case of bovine spongiform encephalopathy (“BSE”). The U.S. Department of Agriculture’s (“USDA”) announcement confirming and explaining this case may be accessed here. According to the USDA, the particular cow involved was a dairy cow, and thus never had contact with any animals intended to enter the nation's food supply. BSE, more commonly known as “mad-cow disease” is a deadly neurological disease in cattle that causes degeneration in the brain and spinal cord. The disease may be spread from diseased cattle…
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